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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; Fallopian Tube Cancer Stage IIIC; Fallopian Tube Cancer Stage IV
• Intervention / Treatment: Procedure: Blood sample collection

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

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Vanseymortier; Phone Number: 03 20 29 59 18; Email: promotion@o-lambret.fr
• Study Contact Backup: Name: Delphine Hudry, MD; Phone Number: 03.20.29.59.59; Email: d-hudry@o-lambret.fr

Study Locations

• France
  • Lille, France, 59020
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Delphine Hudry, MD; Phone Number: 03 20 29 59 59; Email: d-hudry@o-lambret.fr
    • Principal Investigator: Delphine Hudry, MD
    • Sub-Investigator: Fabrice Narducci, MD
    • Sub-Investigator: Annick Chevalier, MD
    • Sub-Investigator: Cyril Abdeddaim, MD
    • Sub-Investigator: Eric Leblanc, MD
    • Sub-Investigator: Emilie Kaczmarek, MD
    • Sub-Investigator: Alfred Bassil, MD
    • Sub-Investigator: Charlotte Bellier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological type on the initial biopsy	To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)	At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment
Clinical response to chemotherapy (post-chemotherapy)	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	At the end of chemotherapy, up to 3 months
Histological response to chemotherapy (no residual disease on excised tissue)	Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy	At the surgery, an average of 6 weeks after inclusion
Progression-free survival	Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause	6 months min to 14 months max
Global survival	Time between diagnosis and death, whatever the cause	6 months min to 14 months max

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Delphine Hudry, MD, Département de cancérologie uro-digestive - Centre Oscar Lambret

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ovarian cancer; HGSOC; Carcinomatosis; Immunological profile; TILs; Tubal Cancer; PBMc
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: TILsOV-1805; Id RCB (Registry Identifier: 2018-A00771-54)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No