NCT00601406Unknown不适用
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 2,200
- 试验地点
- 11
- 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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patients must have received curative external-beam radiotherapy within the context of a formal clinical study for any of the following:
- •Early breast cancer after breast-conserving surgery
- •Localized prostate cancer
- •Gynecological cancer (may have also received brachytherapy)
- •Venous blood samples must be available
- •Patients will be identified from the following clinical studies:
- •Cambridge intensity-modulated radiotherapy breast randomized trial
- •RT01 prostate radiotherapy randomized trial/other prostate trials
- •Christie hospital breast, prostate, and gynecological cancer radiotherapy patients
- •Must have minimum follow up with late normal tissue effect scoring for two years available
- •PATIENT CHARACTERISTICS:
- •No other malignancy prior to treatment for the specified tumor types except basal cell or squamous cell carcinoma of the skin or in situ carcinoma
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
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
研究点 (11)
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