跳至主要内容
临床试验/NCT00601406
NCT00601406Unknown不适用

Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)

The Christie NHS Foundation Trust22 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,200
试验地点
22
主要终点
Correlation of association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, with individual patient variability in normal tissue radiation response and toxicity

研究概览

简要总结

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of external-beam radiation therapy in patients with early breast cancer, localized prostate cancer, or gynecologic cancer.

详细描述

OBJECTIVES:

Primary

  • To test the hypothesis that an association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, is associated with individual patient variability in normal tissue radiation response and toxicity.

Secondary

  • To compare different clinical scoring systems for late normal tissue effects, specifically Late Effect of Normal Tissue Subjective Objective Management Analysis (LENT SOMA), Radiation Therapy Oncology Group (RTOG), quality of life, and in a subset common terminology criteria (CTC) version 3.
  • To compare clinical scoring systems with analytical measures of normal tissue outcome in a minority of patients, using volume change in the breast measured by laser camera.
  • To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history.
  • To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results.
  • To correlate actuarial analysis of late effects changes over time with PRS.
  • To conduct PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability.

研究设计

研究类型
Interventional
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation of association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, with individual patient variability in normal tissue radiation response and toxicity

次要结局

  • Comparison of different clinical scoring systems for late normal tissue effects
  • Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera
  • Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)
  • Comparison of detailed 3D dose-volume analysis with late effects and SNP results
  • Correlation of actuarial analysis of late effects changes over time with PRS
  • PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability

研究者

申办方类型
Other

研究点 (22)

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