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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
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
Centre Oscar Lambret
Lille, France, France
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
Time frame: 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
Time frame: At the end of chemotherapy (post-CT), up to 3 months
Histological type on the initial biopsy
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
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
Time frame: 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
Time frame: 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
Time frame: 6 months min to 14 months max
Global survival
Time between diagnosis and death, whatever the cause
Time frame: 6 months min to 14 months max
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