Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer
- Conditions
- Fallopian Tube Cancer Stage IIICFallopian Tube Cancer Stage IVOvarian Cancer Stage IIICOvarian Cancer Stage IV
- Interventions
- Procedure: Blood sample collection
- Registration Number
- NCT03922776
- Lead Sponsor
- Centre Oscar Lambret
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 36
- 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
- Stage IV with visceral metastases (pulmonary, hepatic ...)
- Contraindication to surgery and / or chemotherapy
- Pregnant or lactating woman
- Patient under guardianship or curatorship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Blood sample collection Blood sample collection 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
- Primary Outcome Measures
Name Time Method Counting of lymphocyte populations (pre-chemotherapy) At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment) 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) At the end of chemotherapy (post-CT), up to 3 months 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
Name Time Method Histological type on the initial biopsy At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)
Clinical response to chemotherapy (post-chemotherapy) At the end of chemotherapy, up to 3 months 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) At the surgery, an average of 6 weeks after inclusion Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy
Progression-free survival 6 months min to 14 months max Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause
Global survival 6 months min to 14 months max Time between diagnosis and death, whatever the cause
Trial Locations
- Locations (1)
Centre Oscar Lambret
🇫🇷Lille, France