HRD Tests for Ovarian cancER
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 5
- 主要终点
- Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).
研究概览
简要总结
The study concerns patients with Invasive epithelial ovarian cancer, primary Fallopian tube carcinoma, ovarian-type peritoneal carcinoma, and with an indication of a first-line platinum-based chemotherapy.
To determine HRD status, 2 separate tests will be performed in the study:
- Giscar assay : developed by the sponsor
- myChoice assay
If one or two tests identifies a HRD status :
a PARP inhibitor treatment may be initiated according to current recommendations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient aged 18-year or more
- •Histologically documented high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer
- •Newly diagnosed advanced (International Federation of Gynecology and Obstetrics [FIGO] stage III or IV) ovarian carcinoma, candidate to a first line platinum-based chemotherapy
- •Tumor tissue must be available for HRD analyses (FFPE tissue block) and
- •Collected if possible during the initial surgery or the initial biopsy (before chemotherapy)
- •With sufficient tumour surface area (> 25 mm²), with a final cellularity of at least 20%
- •Patient affiliated to an appropriate social security system
- •Patient signed consent form before any trial related activities
排除标准
- •Recurrent high grade serous epithelial ovarian cancer, fallopian tube or peritoneum cancer
- •Non epithelial or borderline ovarian cancer
- •Other tumor, for which the treatment may interfere with the ovarian cancer treatment and/or that may have a major impact on prognosis
- •Exclusive palliative setting
- •Patient deprived of liberty or placed under the authority of a tutor
结局指标
主要结局
Rate of platinum-sensitive ovarian cancer patients according to GIScar HRD signature (classified into HRD or HRP).
时间窗: six months after the end of platinum-based chemotherapy
Evaluate Platinum-sensitivity patients (defined as absence of disease progression, according to RECIST 1.1 criteria, six months after a first-line platinum-based chemotherapy) correlated with Homologous Recombination status in tumor (HRD : Homologous Recombination deficient / HRP :Homologous Recombination Proficient)
次要结局
未报告次要终点