Retrospective Study to Develop a Training Set for a Cross Validated Chemoresponse Marker Algorithm in Cases With Ovarian, Peritoneal or Fallopian Tube Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to improve upon and validate the prognostic and/or predictive accuracy of a drug response marker by the development of improved alternative algorithms based on the actual clinical outcome of retrospective cases.
详细描述
This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 512 cases will be collected from approximately 30 sites and correlated to the secondary endpoints identified in order to produce a training set that will incorporate additional improvements to the existing ChemoFx scoring system. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy.
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
- •Case has an original pathology report showing, epithelial ovarian, peritoneal, or fallopian tube carcinoma.
- •Cases must meet one of the following classifications: Recurrent: Complete Response following primary therapy and a period of absence of no measurable disease; Persistent: Partial Response following 6 cycles of a platinum based therapy with measurable disease remaining or Refractory: Stable Disease or Progressive Disease during primary platinum therapy.
- •Case must have a commercial ChemoFx drug response marker final report
排除标准
- •Cases with evidence of synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtype, including papillary serous, clear cell, or other FIGO Grade 3 lesion.