Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer (TILsOV-1805)
Primary Purpose
Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC, Fallopian Tube Cancer Stage IV
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
About this trial
This is an interventional other trial for Ovarian Cancer Stage IIIC focused on measuring Ovarian cancer, Tubal Cancer, Immunological profile, PBMc, TILs, Carcinomatosis, HGSOC
Eligibility Criteria
Inclusion Criteria:
- 18 years old or more
- Presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a diagnostic laparoscopy
- Stage IIIC or initial pleural IV
- Planned treatment with surgery and adjuvant chemotherapy, or neo-adjuvant chemotherapy followed by surgery +/- adjuvant chemotherapy
- Having been informed and signed the informed consent of this study
- Affiliated with a social security scheme
Exclusion Criteria:
- Stage IV with visceral metastases (pulmonary, hepatic ...)
- Contraindication to surgery and / or chemotherapy
- Pregnant or lactating woman
- Patient under guardianship or curatorship
Sites / Locations
- Centre Oscar LambretRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood sample collection
Arm Description
Participants will receive the following interventions because they are enrolled in the study: blood sample collection at diagnosis, before chemotherapy (pre-CT) after chemotherapy (post-ct) Intervention : Collection of two blood samples (5mL) before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment and then, after chemotherapy (post-CT), up to 3 months after enrollment
Outcomes
Primary Outcome Measures
Counting of lymphocyte populations (pre-chemotherapy)
For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint
Counting of lymphocyte populations (post-chemotherapy)
For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint
Secondary Outcome Measures
Histological type on the initial biopsy
To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)
Clinical response to chemotherapy (post-chemotherapy)
In patients receiving neo-adjuvant chemotherapy, clinical response to chemotherapy defined by a partial or complete radiological response (assessed on the thoraco-abdominopelvic CT scan), associated with a decrease in CA125 and a disappearance of ascites in case of ascites at inclusion
Histological response to chemotherapy (no residual disease on excised tissue)
Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy
Progression-free survival
Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause
Global survival
Time between diagnosis and death, whatever the cause
Full Information
NCT ID
NCT03922776
First Posted
January 30, 2019
Last Updated
October 5, 2021
Sponsor
Centre Oscar Lambret
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03922776
Brief Title
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer
Acronym
TILsOV-1805
Official Title
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. The planned interventions are collection of biological samples at different times. The study will aim to describe the immunological profile at diagnosis in terms of phenotypic : PBMCs (peripheral blood, mononuclear cells) in peripheral blood, TILs (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.
Detailed Description
Participants will receive the following interventions because they are enrolled in the study: blood sample collection
at diagnosis, before chemotherapy (pre-CT)
after chemotherapy (post-ct)
Two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy.
The aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : PBMC in peripheral blood, TILs in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. The treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy.
Other objectives of the study include:
Evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension)
Evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery)
Evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic
Evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy
Collect biological material for peritoneal carcinomatosis for subsequent biological analyzes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC, Fallopian Tube Cancer Stage IV, Ovarian Cancer Stage IV
Keywords
Ovarian cancer, Tubal Cancer, Immunological profile, PBMc, TILs, Carcinomatosis, HGSOC
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood sample collection
Arm Type
Experimental
Arm Description
Participants will receive the following interventions because they are enrolled in the study: blood sample collection
at diagnosis, before chemotherapy (pre-CT)
after chemotherapy (post-ct)
Intervention : Collection of two blood samples (5mL)
before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
and then, after chemotherapy (post-CT), up to 3 months after enrollment
Intervention Type
Procedure
Intervention Name(s)
Blood sample collection
Intervention Description
Participants will receive the following interventions because they are enrolled in the study: blood sample collection
at diagnosis, before chemotherapy (pre-CT)
after chemotherapy (post-ct) Collection of two blood samples (5mL),
before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
and then, after chemotherapy (post-CT), up to 3 months after enrollment
Primary Outcome Measure Information:
Title
Counting of lymphocyte populations (pre-chemotherapy)
Description
For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint
Time Frame
At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment)
Title
Counting of lymphocyte populations (post-chemotherapy)
Description
For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint
Time Frame
At the end of chemotherapy (post-CT), up to 3 months
Secondary Outcome Measure Information:
Title
Histological type on the initial biopsy
Description
To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)
Time Frame
At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment
Title
Clinical response to chemotherapy (post-chemotherapy)
Description
In patients receiving neo-adjuvant chemotherapy, clinical response to chemotherapy defined by a partial or complete radiological response (assessed on the thoraco-abdominopelvic CT scan), associated with a decrease in CA125 and a disappearance of ascites in case of ascites at inclusion
Time Frame
At the end of chemotherapy, up to 3 months
Title
Histological response to chemotherapy (no residual disease on excised tissue)
Description
Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy
Time Frame
At the surgery, an average of 6 weeks after inclusion
Title
Progression-free survival
Description
Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause
Time Frame
6 months min to 14 months max
Title
Global survival
Description
Time between diagnosis and death, whatever the cause
Time Frame
6 months min to 14 months max
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women in a study of ovarian cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old or more
Presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a diagnostic laparoscopy
Stage IIIC or initial pleural IV
Planned treatment with surgery and adjuvant chemotherapy, or neo-adjuvant chemotherapy followed by surgery +/- adjuvant chemotherapy
Having been informed and signed the informed consent of this study
Affiliated with a social security scheme
Exclusion Criteria:
Stage IV with visceral metastases (pulmonary, hepatic ...)
Contraindication to surgery and / or chemotherapy
Pregnant or lactating woman
Patient under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Vanseymortier
Phone
03 20 29 59 18
Email
promotion@o-lambret.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Hudry, MD
Phone
03.20.29.59.59
Email
d-hudry@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine Hudry, MD
Organizational Affiliation
Département de cancérologie uro-digestive - Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Hudry, MD
Phone
03 20 29 59 59
Email
d-hudry@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Delphine Hudry, MD
First Name & Middle Initial & Last Name & Degree
Fabrice Narducci, MD
First Name & Middle Initial & Last Name & Degree
Cyril Abdeddaim, MD
First Name & Middle Initial & Last Name & Degree
Annick Chevalier, MD
First Name & Middle Initial & Last Name & Degree
Eric Leblanc, MD
First Name & Middle Initial & Last Name & Degree
Emilie Kaczmarek, MD
First Name & Middle Initial & Last Name & Degree
Alfred Bassil, MD
First Name & Middle Initial & Last Name & Degree
Charlotte Bellier, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer
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