search
Back to results

Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients (ONCOPRO)

Primary Purpose

Cancer, Breast Cancer, Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood draws
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer focused on measuring dd, TUMOR MARKER, PROGASTRIN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Histologically and/or cytologically documented (documentation obtained before or after diagnostic surgical procedure when clinical suspicion is strong), cancers for the following cohorts:

    o Breast carcinomas

    o Gastric carcinomas

    o Renal carcinomas

    o Prostate carcinomas

    o Lung carcinomas: NSCLC and SCLC

    o Hepatocellular carcinomas

    o Colorectal carcinomas

    • Head and neck carcinomas
    • Thyroid cancer
    • Pancreatic carcinomas
    • Ovarian adenocarcinomas
    • Glioblastoma
    • Endometrial adenocarcinomas
    • Bladder carcinoma
    • Superficial Oesophago-gastric carcinomas
    • Diffuse Large B-cell Lymphomas
  • Patient older than 18 years.
  • Patients who gave its written informed consent to participate to the study
  • Patients affiliated to a social insurance regime

Specific inclusion criteria for curative treatment strategy cancer patients:

  • Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents…)
  • Patient naïve of anticancer treatments for the considered cancer
  • A prior anti-cancer treatment is allowed if this treatment was performed with curative intent, and if it did not include systemic chemotherapy, and if a complete remission ≥ 6 months was observed in between the end of treatment and relapse. Previous local treatments for superficial lesions are allowed without any time restriction (for example among others, intravesical treatment for superficial bladder cancer lesions).

Specific inclusion criteria for non-curative treatment strategy cancer patients:

  • Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, …)
  • Patient naïve of anticancer treatments in non-curative setting (except for metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).

The following tumor type specific inclusion criteria must be met in addition to the inclusion criteria listed above:

Breast carcinomas

• All cohorts:

  • Invasive breast ductal carcinoma, or
  • Invasive breast lobular carcinoma

    • Curative intent treatment patient cohort:
  • Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant chemotherapy and/or anti-hormone treatment

Gastric carcinomas

  • All cohorts:

    o Intestinal-type adenocarcinoma, or

    o Diffuse cell type adenocarcinoma

  • Curative intent treatment patient cohort:

    • Planned to be treated with surgery with/without neo-adjuvant treatment, with/without adjuvant treatment

Renal carcinomas • All cohorts:

  • Any histology of renal cancer is accepted (non-clear cell renal cancer could be included)
  • A pathology proof of renal cell carcinoma is not necessarily provided if patients present typical radiologic characteristics of renal cancer on imaging

    • Curative intent treatment patients cohort:

  • Planned to be treated with partial or total nephrectomy

Prostate carcinomas

  • Curative intent treatment patients cohort:

    o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or Gleason >= 4+3 and/or PSA >= 20 and/or N+

    o Planned to be treated with radical prostatectomy or radiotherapy (potentially associated with androgen deprivation therapy). Brachytherapy and/or focused ultrasounds are not allowed.

  • Non-curative intent treatment patients cohort:

    • Patients with metastatic castration resistant prostate cancer (mCRPC) defined by validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide). Patients have to be naïve of treatment for the castration resistant mCRPC. Patients that previously received docetaxel or a 1st or 2nd generation hormonotherapy for their hormone-sensitive prostate cancer in metastatic setting can be included.

Lung carcinomas treated by immunotherapy :

• Non-curative intent patients cohort:

o NSCLC stage IV according to 8th TNM classification planned to be treated with immunotherapy, with/ without chemotherapy

Lung carcinomas excluding those treated with immunotherapy:

  • Curative intent treatment patients cohort:

    o NSCLC histology only

    o Stage I-II according to 8th TNM classification

    o Stage IIIA-B according to 8th TNM classification

    o Planned to be treated with radical treatment (surgery or radiotherapy with/without concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant treatment

  • Non-curative intent patients cohort:

    • NSCLC or SCLC stage IV according to 8th TNM classification planned to be treated with a first line of chemotherapy, with/without associated treatments except immunotherapy (radiotherapy, targeted therapies…). Immunotherapy can be administrated for the subsequent lines of treatment.

Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if patients present typical radiologic characteristics of hepatocellular carcinoma on imaging

  • Absence or chronic hepatic encephalopathy, absence of refractory ascites

    • Curative intent treatment patients cohort:
  • Indication of a treatment strategy with curative intent, except liver transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).

    • Non-curative intent patients cohort:

  • Indication of a treatment strategy with no curative intent: transarterial intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or monoclonal antibodies) or immune therapy.

Colorectal carcinomas

• Curative intent treatment patients cohort:

o Lieberkühn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +/- targeted agent and interval surgery

Head and neck carcinomas

  • All cohorts

    o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx

  • Curative intent treatment patients cohort:

    o Planned to be treated with a radical treatment (surgery and/or radiotherapy potentially associated with concurrent chemotherapy) with/without neo-adjuvant/adjuvant chemotherapy.

  • Non-curative intent treatment patients cohort:

    o De novo metastatic or metastatic/loco-regional relapse planned to be treated with chemotherapy and/or immunotherapy

Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated, poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment is indicated (Iodine treatment will be discussed after surgery. In the case the histological result does not confirm a high risk thyroid cancer, patient will be withdrawn from the study. In the same way, if a iodine treatment is not recommended after surgery, patient will be withdrawn from the study. In both cases, patient will be replaced).

Pancreatic carcinomas

• Curative intent patients cohort:

o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or radiotherapy

Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort:

o 1st platinum-sensitive relapse

  • High or low grade epithelial adenocarcinomas or carcinosarcoma
  • Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/- interval debulking surgery

Glioblastoma • Curative intent patients cohort:

o Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy

Endometrial adenocarcinomas

  • Non-curative intent patients cohort:

    o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers

    o Planned to be treated with non-curative systemic treatment for metastatic or advanced disease

Bladder carcinoma

  • Transitional cell carcinoma • Curative intent treatment patients:
  • Patients with localized muscle invasive bladder cancer (>=PT2)
  • Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or immunotherapy or a combination of chemotherapy and immunotherapy

Superficial Oesophago-gastric cancer • Curative intent patients cohort:

o Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of Stage T1 planned to be treated by endoscopic surgery

Diffuse Large B-Cell Lymphoma (DLBCL)

• Curative intent patients cohort:

o Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)

Sites / Locations

  • Service de NEURO-ONCOLOGIE du Groupement Hospitalier ESTRecruiting
  • Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-RousseRecruiting
  • Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. HerriotRecruiting
  • Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-RousseRecruiting
  • Service d'Urologie de l'Hôpital E. HerriotRecruiting
  • Service de Gynécologie de l'hôpital de la Croix-RousseRecruiting
  • Service de Gynécologie du Groupement Hospitalier EstRecruiting
  • Service de Pneumologie de l'hôpital de la Croix-RousseRecruiting
  • Service de Pneumologie du Groupement Hospitalier EstRecruiting
  • Service d'Hématologie de l'Hôpital Lyon SudRecruiting
  • Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon SudRecruiting
  • Service d'Oncologie médicale du Centre hospitalier Lyon SudRecruiting
  • Service d'Urologie de l'hôpital Lyon SudRecruiting
  • Service de Chirurgie de l'hôpital Lyon SudRecruiting
  • Service de Dermatologie de l'hôpital Lyon SudRecruiting
  • Service de Gynécologie de l'hôpital Lyon SudRecruiting
  • Service de Pneumologie de l'Hôpital Lyon SudRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cancer patients

Arm Description

420 patients affected by different types of cancer and treated in a curative or a palliative intent. In total 17 cohorts will be open, including: breast cancer, head and neck carcinomas, renal cell carcinoma, prostate carcinoma, lung carcinoma, hepatocellular carcinoma, colorectal carcinoma, thyroid cancer, pancreatic adenocarcinoma, ovarian adenocarcinoma, glioblastoma, endometrial adenocarcinoma, bladder carcinoma, oesophago-gastric carcinoma, B-cell lymphoma, gastric carcinomas. Patients enrolled in curative intent treatment cohorts will never have been previously treated for their cancer. Patients enrolled in non-curative intent treatment cohorts will have never been treated for their metastatic cancers previously, or have developed advanced/metastatic diseases as relapses of localized cancers previously treated with curative intent therapeutic strategies. Other cohort will be open (stability cohorts) : nychtemer cohort and post-operative kinetic cohort.

Outcomes

Primary Outcome Measures

ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.

Secondary Outcome Measures

Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest
A nonlinear mixed effect model will be used to model the progastrin measurements done during treatments and follow-up of patients.The effect of each event (chemotherapy, surgery…) on the progastrin value and in the inter-individual variability of production and/or elimination rates of progastrin will be analyzed. Progastrin will be measured by ELISA, and the values will be expressed in pM. Measures will be done depending on the treatment received. Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients.
Nycthemeral and weekly and post-operative progastrin variations
24 patients will be selected, upon their agreement and serum high levels, to enter in nychtemer (12 patients) or weekly (12 patients) cohorts. For the Nychtemer cohort, progastrin will be assayed at d1 at 8:00 am; 11:00 am; 2:00 pm; 5:00 pm; 8:00 pm and at d2 at 8:00 For the weekly cohort, progastrin will be assayed Day 1; Day 8; Day 15 and +/- Day 22; ideally on the same hour times. Progastrin will be measured by ELISA, and the values will be expressed in pM.
Determinants of progastrin serum values: hepatic function
A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (hepatic function, as measured by the concentration of AST, ALT and bilirubin). Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients
Determinants of progastrin serum values: renal function
A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (renal function, as measured by creatinin concentration and creatinin clearance). Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients
Determinants of progastrin serum values: age
A nonlinear mixed effect model will be used to correlate the individual characteristics of the patient (age and gender) with progastrin concentration at the inclusion.
Determinants of progastrin serum values: gender
A nonlinear mixed effect model will be used to correlate genders with progastrin concentrations at the inclusion.
Overall survival
The relationships between the progastrin kinetics during and after treatment and overall survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment. Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
recurrence free survival
The relationships between the progastrin kinetics during and after treatment and recurrence free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment. Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
progression free survival
The relationships between the progastrin kinetics during and after treatment and progression free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment. Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
The tumor size at cancer diagnosis
The size of the tumor will be correlated to progastrin concentration at the time of cancer diagnosis
Complete surgery
The ability of progastrin kinetics during the neoadjuvant period to predict the outcome of the surgery (complete or not) will be analyzed by a ROC curve. If applicable.
time to recurrence (for patients enrolled in curative intent cohorts).
The ability of the progastrin kinetics to predict recurrence free survival (curative cohorts), will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up.
time to progression (for patients enrolled in non-curative intent cohorts)
The ability of the progastrin kinetics to predict progression-free survival (non-curative cohorts) will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up
time to death (whenever it occurred)
The ability of the progastrin kinetics to predict time to death will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up
Comparison of the initial values and of the kinetics of other serum tumor markers (CA15-3, CA 19-9, CA125, CEA, PSA, AFP) with those of progastrin
The ROC AUC will be compared between classical markers and the prograstrin. Logistic regression will be used to combine the classical marker(s) and the progastrin in order to estimate the diagnostic value of the marker combination. progastrin, CA15-3, CA19-9, CA125, CEA, PSA and AFP concentration will be measured on blood sample taken at the inclusion.

Full Information

First Posted
October 26, 2018
Last Updated
July 12, 2021
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT03787056
Brief Title
Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
Acronym
ONCOPRO
Official Title
Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
January 4, 2028 (Anticipated)
Study Completion Date
January 4, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal. In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development. Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation. Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast Cancer, Gastric Cancer, Renal Cancer, Prostate Cancer, Melanoma, Lung Cancer, Hepatocellular Cancer, Colorectal Cancer, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer, Glioblastoma, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, B-cell Lymphoma
Keywords
dd, TUMOR MARKER, PROGASTRIN

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cancer patients
Arm Type
Other
Arm Description
420 patients affected by different types of cancer and treated in a curative or a palliative intent. In total 17 cohorts will be open, including: breast cancer, head and neck carcinomas, renal cell carcinoma, prostate carcinoma, lung carcinoma, hepatocellular carcinoma, colorectal carcinoma, thyroid cancer, pancreatic adenocarcinoma, ovarian adenocarcinoma, glioblastoma, endometrial adenocarcinoma, bladder carcinoma, oesophago-gastric carcinoma, B-cell lymphoma, gastric carcinomas. Patients enrolled in curative intent treatment cohorts will never have been previously treated for their cancer. Patients enrolled in non-curative intent treatment cohorts will have never been treated for their metastatic cancers previously, or have developed advanced/metastatic diseases as relapses of localized cancers previously treated with curative intent therapeutic strategies. Other cohort will be open (stability cohorts) : nychtemer cohort and post-operative kinetic cohort.
Intervention Type
Other
Intervention Name(s)
Blood draws
Intervention Description
Blood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered : Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit Chemotherapy treatment : every 3 or 4 weeks Radiotherapy : start day and at the end of radiation ("end of treatment" visit) Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion In case of PD or TOX Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort
Primary Outcome Measure Information:
Title
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
Description
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest
Description
A nonlinear mixed effect model will be used to model the progastrin measurements done during treatments and follow-up of patients.The effect of each event (chemotherapy, surgery…) on the progastrin value and in the inter-individual variability of production and/or elimination rates of progastrin will be analyzed. Progastrin will be measured by ELISA, and the values will be expressed in pM. Measures will be done depending on the treatment received. Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients.
Time Frame
6 years
Title
Nycthemeral and weekly and post-operative progastrin variations
Description
24 patients will be selected, upon their agreement and serum high levels, to enter in nychtemer (12 patients) or weekly (12 patients) cohorts. For the Nychtemer cohort, progastrin will be assayed at d1 at 8:00 am; 11:00 am; 2:00 pm; 5:00 pm; 8:00 pm and at d2 at 8:00 For the weekly cohort, progastrin will be assayed Day 1; Day 8; Day 15 and +/- Day 22; ideally on the same hour times. Progastrin will be measured by ELISA, and the values will be expressed in pM.
Time Frame
every 3 hours within 24 hours for the Nycthemeral cohort, and every week for 2 or 3 weeks for the weekly cohort
Title
Determinants of progastrin serum values: hepatic function
Description
A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (hepatic function, as measured by the concentration of AST, ALT and bilirubin). Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients
Time Frame
6 years
Title
Determinants of progastrin serum values: renal function
Description
A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (renal function, as measured by creatinin concentration and creatinin clearance). Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients
Time Frame
6 years
Title
Determinants of progastrin serum values: age
Description
A nonlinear mixed effect model will be used to correlate the individual characteristics of the patient (age and gender) with progastrin concentration at the inclusion.
Time Frame
at the inclusion
Title
Determinants of progastrin serum values: gender
Description
A nonlinear mixed effect model will be used to correlate genders with progastrin concentrations at the inclusion.
Time Frame
at the inclusion
Title
Overall survival
Description
The relationships between the progastrin kinetics during and after treatment and overall survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment. Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
Time Frame
6 years
Title
recurrence free survival
Description
The relationships between the progastrin kinetics during and after treatment and recurrence free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment. Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
Time Frame
6 years
Title
progression free survival
Description
The relationships between the progastrin kinetics during and after treatment and progression free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment. Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
Time Frame
6 years
Title
The tumor size at cancer diagnosis
Description
The size of the tumor will be correlated to progastrin concentration at the time of cancer diagnosis
Time Frame
At baseline
Title
Complete surgery
Description
The ability of progastrin kinetics during the neoadjuvant period to predict the outcome of the surgery (complete or not) will be analyzed by a ROC curve. If applicable.
Time Frame
6 years
Title
time to recurrence (for patients enrolled in curative intent cohorts).
Description
The ability of the progastrin kinetics to predict recurrence free survival (curative cohorts), will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up.
Time Frame
6 years
Title
time to progression (for patients enrolled in non-curative intent cohorts)
Description
The ability of the progastrin kinetics to predict progression-free survival (non-curative cohorts) will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up
Time Frame
6 years
Title
time to death (whenever it occurred)
Description
The ability of the progastrin kinetics to predict time to death will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up
Time Frame
6 years
Title
Comparison of the initial values and of the kinetics of other serum tumor markers (CA15-3, CA 19-9, CA125, CEA, PSA, AFP) with those of progastrin
Description
The ROC AUC will be compared between classical markers and the prograstrin. Logistic regression will be used to combine the classical marker(s) and the progastrin in order to estimate the diagnostic value of the marker combination. progastrin, CA15-3, CA19-9, CA125, CEA, PSA and AFP concentration will be measured on blood sample taken at the inclusion.
Time Frame
at the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologically and/or cytologically documented (documentation obtained before or after diagnostic surgical procedure when clinical suspicion is strong), cancers for the following cohorts: o Breast carcinomas o Gastric carcinomas o Renal carcinomas o Prostate carcinomas o Lung carcinomas: NSCLC and SCLC o Hepatocellular carcinomas o Colorectal carcinomas Head and neck carcinomas Thyroid cancer Pancreatic carcinomas Ovarian adenocarcinomas Glioblastoma Endometrial adenocarcinomas Bladder carcinoma Superficial Oesophago-gastric carcinomas Diffuse Large B-cell Lymphomas Patient older than 18 years. Patients who gave its written informed consent to participate to the study Patients affiliated to a social insurance regime Specific inclusion criteria for curative treatment strategy cancer patients: Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents…) Patient naïve of anticancer treatments for the considered cancer A prior anti-cancer treatment is allowed if this treatment was performed with curative intent, and if it did not include systemic chemotherapy, and if a complete remission ≥ 6 months was observed in between the end of treatment and relapse. Previous local treatments for superficial lesions are allowed without any time restriction (for example among others, intravesical treatment for superficial bladder cancer lesions). Specific inclusion criteria for non-curative treatment strategy cancer patients: Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, …) Patient naïve of anticancer treatments in non-curative setting (except for metastatic hormone-sensitive prostate cancer, see specific inclusion criteria). The following tumor type specific inclusion criteria must be met in addition to the inclusion criteria listed above: Breast carcinomas • All cohorts: Invasive breast ductal carcinoma, or Invasive breast lobular carcinoma Curative intent treatment patient cohort: Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant chemotherapy and/or anti-hormone treatment Gastric carcinomas All cohorts: o Intestinal-type adenocarcinoma, or o Diffuse cell type adenocarcinoma Curative intent treatment patient cohort: Planned to be treated with surgery with/without neo-adjuvant treatment, with/without adjuvant treatment Renal carcinomas • All cohorts: Any histology of renal cancer is accepted (non-clear cell renal cancer could be included) A pathology proof of renal cell carcinoma is not necessarily provided if patients present typical radiologic characteristics of renal cancer on imaging • Curative intent treatment patients cohort: Planned to be treated with partial or total nephrectomy Prostate carcinomas Curative intent treatment patients cohort: o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or Gleason >= 4+3 and/or PSA >= 20 and/or N+ o Planned to be treated with radical prostatectomy or radiotherapy (potentially associated with androgen deprivation therapy). Brachytherapy and/or focused ultrasounds are not allowed. Non-curative intent treatment patients cohort: Patients with metastatic castration resistant prostate cancer (mCRPC) defined by validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide). Patients have to be naïve of treatment for the castration resistant mCRPC. Patients that previously received docetaxel or a 1st or 2nd generation hormonotherapy for their hormone-sensitive prostate cancer in metastatic setting can be included. Lung carcinomas treated by immunotherapy : • Non-curative intent patients cohort: o NSCLC stage IV according to 8th TNM classification planned to be treated with immunotherapy, with/ without chemotherapy Lung carcinomas excluding those treated with immunotherapy: Curative intent treatment patients cohort: o NSCLC histology only o Stage I-II according to 8th TNM classification o Stage IIIA-B according to 8th TNM classification o Planned to be treated with radical treatment (surgery or radiotherapy with/without concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant treatment Non-curative intent patients cohort: NSCLC or SCLC stage IV according to 8th TNM classification planned to be treated with a first line of chemotherapy, with/without associated treatments except immunotherapy (radiotherapy, targeted therapies…). Immunotherapy can be administrated for the subsequent lines of treatment. Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if patients present typical radiologic characteristics of hepatocellular carcinoma on imaging Absence or chronic hepatic encephalopathy, absence of refractory ascites Curative intent treatment patients cohort: Indication of a treatment strategy with curative intent, except liver transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm). • Non-curative intent patients cohort: Indication of a treatment strategy with no curative intent: transarterial intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or monoclonal antibodies) or immune therapy. Colorectal carcinomas • Curative intent treatment patients cohort: o Lieberkühn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +/- targeted agent and interval surgery Head and neck carcinomas All cohorts o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx Curative intent treatment patients cohort: o Planned to be treated with a radical treatment (surgery and/or radiotherapy potentially associated with concurrent chemotherapy) with/without neo-adjuvant/adjuvant chemotherapy. Non-curative intent treatment patients cohort: o De novo metastatic or metastatic/loco-regional relapse planned to be treated with chemotherapy and/or immunotherapy Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated, poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment is indicated (Iodine treatment will be discussed after surgery. In the case the histological result does not confirm a high risk thyroid cancer, patient will be withdrawn from the study. In the same way, if a iodine treatment is not recommended after surgery, patient will be withdrawn from the study. In both cases, patient will be replaced). Pancreatic carcinomas • Curative intent patients cohort: o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or radiotherapy Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort: o 1st platinum-sensitive relapse High or low grade epithelial adenocarcinomas or carcinosarcoma Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/- interval debulking surgery Glioblastoma • Curative intent patients cohort: o Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy Endometrial adenocarcinomas Non-curative intent patients cohort: o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers o Planned to be treated with non-curative systemic treatment for metastatic or advanced disease Bladder carcinoma Transitional cell carcinoma • Curative intent treatment patients: Patients with localized muscle invasive bladder cancer (>=PT2) Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or immunotherapy or a combination of chemotherapy and immunotherapy Superficial Oesophago-gastric cancer • Curative intent patients cohort: o Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of Stage T1 planned to be treated by endoscopic surgery Diffuse Large B-Cell Lymphoma (DLBCL) • Curative intent patients cohort: o Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoit YOU, MD
Phone
04 78 86 43 53
Ext
+33
Email
benoit.you@hu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sara CALATTINI
Phone
04 78 86 37 79
Ext
+33
Email
sara.calattini@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit YOU, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois DUCRAY, MD
Email
francois.ducray@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Francois DUCRAY, MD
Facility Name
Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marielle GUILLET, MD
Email
marielle.guillet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marielle GUILLET, MD
First Name & Middle Initial & Last Name & Degree
Philippe MERLE, MD
Facility Name
Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas WALTER, MD
Email
thomas.walter@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Thomas WALTER, MD
First Name & Middle Initial & Last Name & Degree
Mathieu PIOCHE, MD
Facility Name
Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine BRUYAS, MD
Email
amandine.bruyas@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Amandine BRUYAS, MD
First Name & Middle Initial & Last Name & Degree
Philippe CERUSE, MD
Facility Name
Service d'Urologie de l'Hôpital E. Herriot
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel BADET, MD
Email
lionel.badet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Lionel BADET, MD
Facility Name
Service de Gynécologie de l'hôpital de la Croix-Rousse
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion CORTET, MD
Email
marion.cortet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marion CORTET, MD
Facility Name
Service de Gynécologie du Groupement Hospitalier Est
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe SAJOUS, MD
Email
christophe.sajous@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Christophe SAJOUS, MD
Facility Name
Service de Pneumologie de l'hôpital de la Croix-Rousse
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles DEVOUASSOUX, MD
Email
gilles.devouassoux@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Gilles DEVOUASSOUX, MD
First Name & Middle Initial & Last Name & Degree
Lize KIAKOUAMA, MD
Facility Name
Service de Pneumologie du Groupement Hospitalier Est
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael DURUISSEAUX, MD
Email
michael.duruisseaux@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Michael DURUISSEAUX, MD
Facility Name
Service d'Hématologie de l'Hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel KARLIN, MD
Email
lionel.karlin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Lionel KARLIN, MD
Facility Name
Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion CHAUVENET, MD
Email
marion.chauvenet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marion CHAUVENET, MD
Facility Name
Service d'Oncologie médicale du Centre hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit YOU, MD
Email
benoit.you@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Benoit YOU, MD
First Name & Middle Initial & Last Name & Degree
Gilles FREYER, MD
First Name & Middle Initial & Last Name & Degree
Véronique TRILLET LENOIR, MD
First Name & Middle Initial & Last Name & Degree
Denis MAILLET, MD
First Name & Middle Initial & Last Name & Degree
Sophie TARTAS, MD
First Name & Middle Initial & Last Name & Degree
Nathalie BONNIN, MD
First Name & Middle Initial & Last Name & Degree
Julien PERON, MD
First Name & Middle Initial & Last Name & Degree
Olivia LE SAUX, MD
Facility Name
Service d'Urologie de l'hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe PAPAREL, MD
Email
philippe.paparel@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Philippe PAPAREL, MD
Facility Name
Service de Chirurgie de l'hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier GLEHEN, MD
Email
olivier.glehen@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Olivier GLEHEN, MD
First Name & Middle Initial & Last Name & Degree
Naoual BAKRIN, MD
Facility Name
Service de Dermatologie de l'hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane DALLE, MD
Email
stephane.dalle@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Stephane DALLE, MD
First Name & Middle Initial & Last Name & Degree
Mona AMINI, MD
Facility Name
Service de Gynécologie de l'hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Adrien BOLZE, MD
Email
pierre-adrien.bolze@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Pierre Adrien BOLZE, MD
Facility Name
Service de Pneumologie de l'Hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien COURAUD, MD
Email
sebastien.couraud@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sebastien COURAUD, MD

12. IPD Sharing Statement

Learn more about this trial

Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

We'll reach out to this number within 24 hrs