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Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer — TILsOV-1805  

Ovarian Cancer Stage IV Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03922776
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Active, not recruiting
Phase N/A
Start date May 16, 2019
Completion date May 2025
View Details
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