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

Centre Oscar Lambret

Status: Active, not recruiting

Conditions: Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; Fallopian Tube Cancer Stage IIIC; Fallopian Tube Cancer Stage IV

Treatments: Procedure: Blood sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT03922776

Id RCB (Registry Identifier)

TILsOV-1805

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Blood sample collection

Experimental group

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) 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

Treatment:

Procedure: Blood sample collection