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

NCT03922776 | Terminated DMC

• 2 other identifiers: TILsOV-18052018-A00771-54
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ovarian cancer; Tubal Cancer; Immunological profile; PBMc; TILs; Carcinomatosis; HGSOC

Outcome Measures

Primary Outcomes (2)

• Counting of lymphocyte populations (pre-chemotherapy)

  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

  At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment)

• Counting of lymphocyte populations (post-chemotherapy)

  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

  At the end of chemotherapy (post-CT), up to 3 months

Secondary Outcomes (5)

• Histological type on the initial biopsy

  At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment

• Clinical response to chemotherapy (post-chemotherapy)

  At the end of chemotherapy, up to 3 months

• Histological response to chemotherapy (no residual disease on excised tissue)

  At the surgery, an average of 6 weeks after inclusion

• Progression-free survival

  6 months min to 14 months max

• Global survival

  6 months min to 14 months max

Study Arms (1)

Blood sample collection

EXPERIMENTAL

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

Procedure: Blood sample collection

Interventions

Blood sample collection 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

Blood sample collection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women in a study of ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Stage IV with visceral metastases (pulmonary, hepatic ...)
• Contraindication to surgery and / or chemotherapy
• Pregnant or lactating woman
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, France, 59020, France

Location

Related Publications (24)

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MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Delphine Hudry, MD

  Département de cancérologie uro-digestive - Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: April 22, 2019
• Study Start: May 17, 2019
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)