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临床试验/NCT02555735
NCT02555735Enrolling By Invitation不适用

Evaluation of Exceptional Responders With Solid Tumor Cancer

Adera Labs, LLC1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
250
试验地点
1
主要终点
Identify exceptional responders with cancer to standard of care chemotherapy

研究概览

简要总结

This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.

详细描述

This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.

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
All
接受健康志愿者

入选标准

  • Histological or cytological confirmation of solid tumor carcinoma.
  • Patient is treatment-naïve or currently receiving chemotherapy.
  • ECOG performance status (any).

排除标准

  • HIV positive on antiretroviral therapy
  • Pregnant or lactating
  • Prior organ allograft
  • Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

研究组 & 干预措施

Solid Tumor Cancer

Participants with solid tumor cancer treated with physician-choice standard of care chemotherapy.

干预措施: Standard of Care Chemotherapy (Drug)

结局指标

主要结局

Identify exceptional responders with cancer to standard of care chemotherapy

时间窗: 9 years

Identify responders and non-responders

次要结局

  • Correlation of genomic profiles from circulating cells with overall survival(9 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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