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

  • STATUS
    Recruiting
  • End date
    Feb 13, 2024
  • participants needed
    55
  • sponsor
    Centre Oscar Lambret
Updated on 4 February 2022
cancer
ascites
ovarian cancer
carcinomatosis

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.

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

Details
Condition Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC, Fallopian Tube Cancer Stage IV, Ovarian Cancer Stage IV
Treatment Blood sample collection
Clinical Study IdentifierNCT03922776
SponsorCentre Oscar Lambret
Last Modified on4 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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