Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer
- Conditions
- Breast CancerCervical CancerEndometrial CancerFallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity CancerProstate CancerSarcomaVaginal CancerVulvar Cancer
- Registration Number
- NCT00601406
- Lead Sponsor
- The Christie NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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) PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability
Trial Locations
- Locations (11)
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Southport and Formby District General Hospital
🇬🇧Southport, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Whiston Hospital
🇬🇧Prescot, England, United Kingdom
Warrington Hospital NHS Trust
🇬🇧Warrington, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom