Fallopian Tube Cancer Stage IIIC, Fallopian Tube Cancer Stage IV, Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Conditions
Keywords
Ovarian cancer, Tubal Cancer, Immunological profile, PBMc, TILs, Carcinomatosis, HGSOC
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
Interventions
PROCEDUREBlood 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) 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
Sponsors
Centre Oscar Lambret
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDelphine Hudry, MD
Département de cancérologie uro-digestive - Centre Oscar Lambret
Outcome results
None listed