Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Counting of lymphocyte populations (pre-chemotherapy)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Stage IV with visceral metastases (pulmonary, hepatic ...)
- •Contraindication to surgery and / or chemotherapy
- •Pregnant or lactating woman
- •Patient under guardianship or curatorship
研究组 & 干预措施
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
干预措施: Blood sample collection (Procedure)
结局指标
主要结局
Counting of lymphocyte populations (pre-chemotherapy)
时间窗: At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment)
For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint
Counting of lymphocyte populations (post-chemotherapy)
时间窗: At the end of chemotherapy (post-CT), up to 3 months
For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint
次要结局
- Histological type on the initial biopsy(At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment)
- Clinical response to chemotherapy (post-chemotherapy)(At the end of chemotherapy, up to 3 months)
- Histological response to chemotherapy (no residual disease on excised tissue)(At the surgery, an average of 6 weeks after inclusion)
- Progression-free survival(6 months min to 14 months max)
- Global survival(6 months min to 14 months max)