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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03922776
Recruitment Status Recruiting
First Posted April 22, 2019
Last update posted April 22, 2019
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.
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
|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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 18 years old or more
- Presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a
- 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
- Stage IV with visceral metastases (pulmonary, hepatic ...)
- Contraindication to surgery and / or chemotherapy
- Pregnant or lactating woman
- Patient under guardianship or curatorship
Contact: Marie Vanseymortier 03 20 29 59 18 email@example.com
Contact: Delphine Hudry, MD 03.20.29.59.59 firstname.lastname@example.org
Centre Oscar Lambret
Centre Oscar Lambret
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Delphine Hudry, MD Département de cancérologie uro-digestive - Centre Oscar Lambret
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