Back to resultsDeciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)
Primary Purpose
Head and Neck Cancer, Ovarian Cancer, Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples, tumor biopsy specimens and ascites samples will be collected.
Sponsored by
About this trial
This is an interventional other trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
- Age ≥ 18 years at the time of study entry
- Patient followed within a standard of care procedure or clinical trial
- ECOG Performance status 0-2
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France
- Patient may participate to other clinical trials
Exclusion Criteria:
- Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
- Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
- Patient pregnant, or breast-feeding
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship
Sites / Locations
- Hopital LarreyRecruiting
- Hopital RangueilRecruiting
- Institut Universitaire du Cancer Toulouse - OncopoleRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with local and/or metastatic solid malignant tumor
Arm Description
Patient receiving an anticancer treatment in the context of their standard care.
Outcomes
Primary Outcome Measures
Percentage of CD4 and CD8 T cells expressing PD-1
Secondary Outcome Measures
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03958240
Brief Title
Deciphering Mechanisms Underlying Cancer Immunogenicity
Acronym
DECIDE
Official Title
Deciphering Mechanisms Underlying Cancer Immunogenicity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
September 2029 (Anticipated)
Study Completion Date
September 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
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
This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.
The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.
Patients with any of the following tumor types may be enrolled in the trial:
Head and neck cancer,
Ovarian cancer,
Cervical cancer,
Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)
Each tumor type will be considered as an independent cohort.
For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.
Study participation of each patient will be 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer
Keywords
Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with local and/or metastatic solid malignant tumor
Arm Type
Other
Arm Description
Patient receiving an anticancer treatment in the context of their standard care.
Intervention Type
Other
Intervention Name(s)
Blood samples, tumor biopsy specimens and ascites samples will be collected.
Intervention Description
Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice):
at Baseline.
at every surgical procedure or tumor biopsy.
every 6 months (± 2 months) (only blood sample).
at the time of the progression or recurrence, if applicable.
For patients undergoing a RT treatment, blood samples will be collected before the RT (i.e. at the time of planning CT-scan), at the last session of RT (± 2 days) and 3 months after the end of the RT (± 2 weeks).
Primary Outcome Measure Information:
Title
Percentage of CD4 and CD8 T cells expressing PD-1
Time Frame
5 years for each patient
Secondary Outcome Measure Information:
Title
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
Time Frame
5 years for each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
Age ≥ 18 years at the time of study entry
Patient followed within a standard of care procedure or clinical trial
ECOG Performance status 0-2
Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
Patient affiliated to a Social Health Insurance in France
Patient may participate to other clinical trials
Exclusion Criteria:
Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
Patient pregnant, or breast-feeding
Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra MARTINEZ
Phone
+33 5 31 15 53 66
Email
martinez.alejandra@iuct-oncopole.fr
Facility Information:
Facility Name
Hopital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien MAZIERES
Phone
05 67 77 18 37
Email
mazieres.j@chu-toulouse.fr
Facility Name
Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosine GUIMBAUD
Phone
05 61 32 21 42
Email
guimbaud.r@chu-toulouse.fr
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra MARTINEZ
Phone
+33 5 31 15 53 66
Email
martinez.alejandra@iuct-oncopole.fr
12. IPD Sharing Statement
Learn more about this trial
Deciphering Mechanisms Underlying Cancer Immunogenicity
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