Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer (TILsOV-1805)
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- STATUS
- Recruiting
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- End date
- Feb 13, 2024
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- participants needed
- 55
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- sponsor
- Centre Oscar Lambret
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 Identifier | NCT03922776 |
| Sponsor | Centre Oscar Lambret |
| Last Modified on | 4 February 2022 |
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