Folate Receptor Alpha Expression in Relapsed Ovarian, Fallopian Tube and Primary Peritoneal Cancer: a Realworld prEvalence Study in Italy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- FRα - Positive Status
研究概览
简要总结
The purpose of this study is to evaluate the prevalence of folate receptor alpha (FRα)-positive status (≥75% viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) in participants with high-grade serous ovarian, fallopian tube, and primary peritoneal cancer, stratified by time of sampling (initial diagnosis versus relapse), adhering to Ventana folate receptor alpha (FOLR1) RxDx (prescription diagnosis) assay Interpretation Guidance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Relapsed ovarian, fallopian tube and primary peritoneal cancer
- •Histologically high-grade serous carcinoma
- •Presence of archived surgical tissue samples from participants with epithelial ovarian cancer at diagnosis and at 1st recurrence in the same participants
- •Available samples collected from January 1st, 2016 to study start date (defined as study site initiation visit date) that are considered adequate for the Ventana folate receptor alpha (FOLR1) RxDx assay by the site pathologist
排除标准
- •Histological ambiguous diagnosis upon review
- •Diagnosis based on cytology and without any biopsy or surgical specimen
- •Other histotypes than high grade serous ovarian cancer, fallopian tube cancer and primary peritoneal cancer
- •Archival or recurrent sample for the same participant not available
研究组 & 干预措施
Folate Receptor Alpha (FRα)
Samples of eligible participants with ovarian cancer will be analyzed retrospectively for folate receptor alpha (FRα) expression.
结局指标
主要结局
FRα - Positive Status
时间窗: Up to Approximately 6 Months
FRα - positive status, defined as ≥75% viable tumor cells demonstrating moderate (2+) and/or strong (3+) membrane staining with the Ventana FOLR1 RxDx assay, at diagnosis and/or at relapse.
次要结局
未报告次要终点