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临床试验/NCT01049126
NCT01049126已完成不适用

Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

Precision Therapeutics1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1

研究概览

简要总结

The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

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 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. 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. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

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

入选标准

  • Case has an original pathology report showing stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer.
  • Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.).
  • Case has been identified for pattern of response evaluation.
  • Case must have a commercial ChemoFx drug response marker final report.

排除标准

  • Cases of patients who were deceased prior to 1 cycle of chemotherapy.

研究者

申办方类型
Industry

研究点 (1)

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