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

Brief Title

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

Official Title

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

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

Study Type

Interventional

Primary Outcome

Counting of lymphocyte populations (pre-chemotherapy)

Secondary Outcome

 Histological type on the initial biopsy

Condition

Ovarian Cancer Stage IIIC

Intervention

Blood sample collection

Study Arms / Comparison Groups

 Blood sample collection

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)
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

May 2019

Completion Date

March 2020

Primary Completion Date

September 2019

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Delphine Hudry, MD, 03 20 29 59 18, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT03922776

Organization ID

TILsOV-1805

Secondary IDs

Id RCB

Responsible Party

Sponsor

Study Sponsor

Centre Oscar Lambret

Collaborators

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

Study Sponsor

Delphine Hudry, MD, Principal Investigator, Département de cancérologie uro-digestive - Centre Oscar Lambret

Verification Date

April 2019