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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03922776

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted April 22, 2019

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:Fallopian Tube Cancer Stage IIIC
    Fallopian Tube Cancer Stage IV
    Ovarian Cancer Stage IIIC
    Ovarian Cancer Stage IV
  • Intervention/Treatment: Procedure: Blood sample collection
  • Phase: N/A
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
  • Estimated Enrollment: 55 participants
  • 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
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: March 2020
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
  • 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
Lille

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

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