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Health Condition(s) or Problem
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Breast Cancer; Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Prostate Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Genetic; gene expression analysis; Genetic; gene rearrangement analysis; Genetic; polymorphism analysis; Other; laboratory biomarker analysis; Radiation; radiation therapy
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Primary aim
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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
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Secondary Aim
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Comparison of different clinical scoring systems for late normal tissue effects; Yes; Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera; Yes; Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS); No; Comparison of detailed 3D dose-volume analysis with late effects and SNP results; No; Correlation of actuarial analysis of late effects changes over time with PRS; No; PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/CHNT-RAPPER
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Brighton, Bristol, Cambridge, Ipswich, Manchester, Merseyside , Prescot, Sheffield , Southport, Sutton, Warrington
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