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
55
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