Breast Cancer Clinical Trial
Official title:
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
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.
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.
OUTLINE: This is a multicenter study.
Patients are recruited from clinical trials in which their late normal tissue effects have
been measured. Blood samples are collected from these patients for analysis of genetic
variation by DNA extraction and single nucleotide polymorphism analysis. Sixty different
genes, including those involved in cell cycle checkpoint control, DNA damage recognition and
repair, induction of apoptosis, and cytokine production (including TGFβ pathways) are
assessed.
;
Masking: Open Label, Primary Purpose: Treatment
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