A Concordance Study of Folate Receptor Alpha (FRa) Testing in InterCon Countries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central)
研究概览
简要总结
Epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm with a 5-year relative survival of approximately 50%. This study will evaluate the concordance in folate receptor alpha (FRa) immunohistochemistry (IHC) in adult female participants with ovarian cancer.
Archived tissue biopsies will be tested for FRa and data from approximately 1,000 participants will be collected. This is a retrospective study and testing will be performed prospectively on archived samples.
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 1 Year.
There is no additional burden for participants in this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Surgical or biopsy samples (Formalin Fixed Paraffin Embedded [FFPE]) with tumoral High Grade Serous Ovarian Cancer (HGSOC) material allowing the sectioning of serial slides for all the analyses.
- •Archival specimens should not be older than 5 years in order to control quality of the samples.
- •Specimens containing a minimum of 100 viable tumor cells.
排除标准
- •Surgical or biopsy samples (FFPE) with insufficient quantity or quality (sampled more than 5 years ago and/or with less 100 viable tumor cells per section).
- •Tissue obtained following treatment with Mirvetuximab soravtansine or any other FRa targeted therapy.
- •Tissue obtained through fine needle aspirations or liquid specimens, or ascites
研究组 & 干预措施
Banked Tissue Samples Undergoing Chart Review
Banked tissue samples undergoing chart review and retrospective folate receptor alpha (FRa) testing of tissue biopsies.
结局指标
主要结局
Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central)
时间窗: Up to Approximately 1 Year
FRa positive overexpression is defined as: tumor cell membrane staining of at least 75% with a 2+ and/or 3+ staining, or FRa negative as: tumor cell membrane staining of less than 75% with a 2+ and/or 3+ staining.
次要结局
未报告次要终点