Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Immune response in PBMC
研究概览
简要总结
This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.
详细描述
The aim is to assess the impact of anti-PARP on peripheral immune populations and the amount of DNA circulating; to correlate these data with tumor infiltration, with the initial clinical characteristics and with the clinical course; compare the immunogenic effect of different anti-PARPs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient over 18 years
- •Patient treated for epithelial ovarian cancer
- •Eligible for anti-PARP therapy and in one of the 2 cohorts below:
- •Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy.
- •2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.
- •Patient having signed the informed consent form.
- •Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.
- •Patient affiliated to the social security system.
排除标准
- •Non-epithelial tumour of the ovary
- •Patient unable to understand, read and/or sign informed consent.
- •Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions.
- •Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.
- •Pregnant or breast-feeding women.
- •HIV and/or HBV and/or HCV serology positive.
- •Patient refusal.
- •Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).
- •Inability to undergo medical follow-up for geographical, social or psychological reasons.
结局指标
主要结局
Immune response in PBMC
时间窗: From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
Realization of a PBMC bank
Immune response in tumor DNA
时间窗: From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
Realization of a circulating tumor DNA bank
Immune response in plasma
时间窗: From date of inclusion until the date of first documented progression or date of death from any cause assessed up to 24 months
Realization of a plasma library
次要结局
未报告次要终点