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| Descriptive Information Fields | |||||
| Brief Title † | 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 | ||||
| Official Title † | Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER) | ||||
| 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | 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 [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Comparison of different clinical scoring systems for late normal tissue effects [ Designated as safety issue: Yes ] Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera [ Designated as safety issue: Yes ] Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS) [ Designated as safety issue: No ] Comparison of detailed 3D dose-volume analysis with late effects and SNP results [ Designated as safety issue: No ] Correlation of actuarial analysis of late effects changes over time with PRS [ Designated as safety issue: 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 [ Designated as safety issue: No ] |
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| Condition † | Breast Cancer Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Prostate Cancer Sarcoma Vaginal Cancer Vulvar Cancer |
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| Intervention † | Procedure: gene expression analysis Procedure: gene rearrangement analysis Procedure: laboratory biomarker analysis Procedure: polymorphism analysis Procedure: radiation therapy |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 2200 | ||||
| Start Date † | March 2006 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00601406 | ||||
| Organization ID | CDR0000581139 | ||||
| Secondary IDs †† | CHNT-RAPPER, EU-20798 | ||||
| Study Sponsor † | Christie Hospital | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | January 25, 2008 | ||||
| Last Updated Date | July 23, 2008 | ||||