Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy

Conditions
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Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC, Fallopian Tube Cancer Stage IV, Ovarian Cancer Stage IV

Intervention / Treatment
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* Procedure: Blood sample collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood sample collection<br>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 | Procedure: Blood sample collection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment) | 
| 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 | At the end of chemotherapy (post-CT), up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological type on the initial biopsy | To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC) | At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment | 
| 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 | At the end of chemotherapy, up to 3 months | 
| 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 | At the surgery, an average of 6 weeks after inclusion | 
| Progression-free survival | Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause | 6 months min to 14 months max | 
| Global survival | Time between diagnosis and death, whatever the cause | 6 months min to 14 months max | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PBMc, Ovarian cancer, Tubal Cancer, Immunological profile, TILs, Carcinomatosis, HGSOC