Clinical trial NCT03922776: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer Stage IIIC
Fallopian Tube Cancer Stage IIIC
Fallopian Tube Cancer Stage IV
Ovarian Cancer Stage IV
Keywords: Ovarian cancer
Tubal Cancer
Immunological profile
PBMc
TILs
Carcinomatosis
HGSOC
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-04-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Counting of lymphocyte populations (pre-chemotherapy)
timeFrame: At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment)
measure: Counting of lymphocyte populations (post-chemotherapy)
timeFrame: At the end of chemotherapy (post-CT), up to 3 months
Secondary outcomes:
measure: Histological type on the initial biopsy
timeFrame: At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment
measure: Clinical response to chemotherapy (post-chemotherapy)
timeFrame: At the end of chemotherapy, up to 3 months
measure: Histological response to chemotherapy (no residual disease on excised tissue)
timeFrame: At the surgery, an average of 6 weeks after inclusion
measure: Progression-free survival
timeFrame: 6 months min to 14 months max
measure: Global survival
timeFrame: 6 months min to 14 months max
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Département de cancérologie uro-digestive - Centre Oscar Lambret
name: Delphine Hudry, MD
role: PRINCIPAL_INVESTIGATOR
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