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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
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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.
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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.
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To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history.
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To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results.
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To correlate actuarial analysis of late effects changes over time with PRS.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Patients must have received curative external-beam radiotherapy within the context of a formal clinical study for any of the following:
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Early breast cancer after breast-conserving surgery
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Localized prostate cancer
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Gynecological cancer (may have also received brachytherapy)
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Venous blood samples must be available
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Patients will be identified from the following clinical studies:
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Cambridge intensity-modulated radiotherapy breast randomized trial
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RT01 prostate radiotherapy randomized trial/other prostate trials
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Christie hospital breast, prostate, and gynecological cancer radiotherapy patients
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sussex Cancer Centre at Royal Sussex County Hospital | Brighton | England | United Kingdom | BN2 5BE |
| 2 | Bristol Haematology and Oncology Centre | Bristol | England | United Kingdom | BS2 8ED |
| 3 | Addenbrooke's Hospital | Cambridge | England | United Kingdom | CB2 2QQ |
| 4 | Ipswich Hospital | Ipswich | England | United Kingdom | IP4 5PD |
| 5 | Christie Hospital | Manchester | England | United Kingdom | M20 4BX |
| 6 | Clatterbridge Centre for Oncology | Merseyside | England | United Kingdom | CH63 4JY |
| 7 | Whiston Hospital | Prescot | England | United Kingdom | L35 5DR |
| 8 | Cancer Research Centre at Weston Park Hospital | Sheffield | England | United Kingdom | S1O 2SJ |
| 9 | Southport and Formby District General Hospital | Southport | England | United Kingdom | PR8 6PN |
| 10 | Royal Marsden - Surrey | Sutton | England | United Kingdom | SM2 5PT |
| 11 | Warrington Hospital NHS Trust | Warrington | England | United Kingdom | WA5 1QG |
Sponsors and Collaborators
- The Christie NHS Foundation Trust
Investigators
- Study Chair: Catherine West, The Christie NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000581139
- CHNT-RAPPER
- EU-20798