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

• ClinicalTrials.gov Identifier: NCT03922776
• Recruitment Status: Recruiting
• First Posted: April 22, 2019
• Last Update Posted: October 6, 2021
• Sponsor: Centre Oscar Lambret
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): Centre Oscar Lambret

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer Stage IIIC; Fallopian Tube Cancer Stage IIIC; Fallopian Tube Cancer Stage IV; Ovarian Cancer Stage IV	Procedure: Blood sample collection	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy
• Actual Study Start Date: May 16, 2019
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: February 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Counting of lymphocyte populations (pre-chemotherapy) [ Time Frame: At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment) ]
   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
2. Counting of lymphocyte populations (post-chemotherapy) [ Time Frame: At the end of chemotherapy (post-CT), up to 3 months ]
   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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women in a study of ovarian cancer
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Marie Vanseymortier; 03 20 29 59 18; promotion@o-lambret.fr

Contact: Delphine Hudry, MD; 03.20.29.59.59; d-hudry@o-lambret.fr

Locations

France

Centre Oscar Lambret; Recruiting

Lille, France, 59020

Contact: Delphine Hudry, MD 03 20 29 59 59 d-hudry@o-lambret.fr

Principal Investigator: Delphine Hudry, MD

Sub-Investigator: Fabrice Narducci, MD

Sub-Investigator: Cyril Abdeddaim, MD

Sub-Investigator: Annick Chevalier, MD

Sub-Investigator: Eric Leblanc, MD

Sub-Investigator: Emilie Kaczmarek, MD

Sub-Investigator: Alfred Bassil, MD

Sub-Investigator: Charlotte Bellier, MD

Sponsors and Collaborators

Centre Oscar Lambret

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

More Information

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• Responsible Party: Centre Oscar Lambret
• ClinicalTrials.gov Identifier: NCT03922776
• Other Study ID Numbers: TILsOV-1805; Id RCB ( Registry Identifier: 2018-A00771-54 )
• First Posted: April 22, 2019
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Oscar Lambret:

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

Additional relevant MeSH terms:

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