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

NCT ID: NCT03922776

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2024-07-31

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Blood sample collection

Intervention Type: PROCEDURE

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

Interventions

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) 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine Hudry, MD

Role: PRINCIPAL_INVESTIGATOR

Département de cancérologie uro-digestive - Centre Oscar Lambret

Locations

Centre Oscar Lambret

Lille, France, France

Countries

France

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Other Identifiers

Id RCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

TILsOV-1805

Identifier Type: -

Identifier Source: org_study_id