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| Sponsored by: |
Christie Hospital |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00601406 |
Purpose
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 | Intervention |
|
Breast Cancer Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Prostate Cancer Sarcoma Vaginal Cancer Vulvar Cancer |
Procedure: gene expression analysis Procedure: gene rearrangement analysis Procedure: laboratory biomarker analysis Procedure: polymorphism analysis Procedure: radiation therapy |
| Genetics Home Reference related topics: | Soft Tissue Sarcoma breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Cervical Cancer Ovarian Cancer Prostate Cancer Soft Tissue Sarcoma Vaginal Cancer Vulvar Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER) |
| Estimated Enrollment: | 2200 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must have received curative external-beam radiotherapy within the context of a formal clinical study for any of the following:
Patients will be identified from the following clinical studies:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United Kingdom, England | |||||
| Addenbrooke's Hospital | Recruiting | ||||
| Cambridge, England, United Kingdom, CB2 2QQ | |||||
| Contact: Contact Person 44-1223-336-800 | |||||
| Bristol Haematology and Oncology Centre | Recruiting | ||||
| Bristol, England, United Kingdom, BS2 8ED | |||||
| Contact: Contact Person 44-117-928-2415 | |||||
| Cancer Research Centre at Weston Park Hospital | Recruiting | ||||
| Sheffield, England, United Kingdom, S1O 2SJ | |||||
| Contact: Contact Person 44-114-226-5000 | |||||
| Christie Hospital | Recruiting | ||||
| Manchester, England, United Kingdom, M20 4BX | |||||
| Contact: Contact Person 44-161-446-8275 | |||||
| Clatterbridge Centre for Oncology | Recruiting | ||||
| Merseyside, England, United Kingdom, CH63 4JY | |||||
| Contact: Contact Person 44-151-334-1155 | |||||
| Whiston Hospital | Recruiting | ||||
| Prescot, England, United Kingdom, L35 5DR | |||||
| Contact: Contact Person 44-151-334-1155 | |||||
| Royal Marsden - Surrey | Recruiting | ||||
| Sutton, England, United Kingdom, SM2 5PT | |||||
| Contact: Contact Person 44-20-8661-3271 | |||||
| Southport and Formby District General Hospital | Recruiting | ||||
| Southport, England, United Kingdom, PR8 6PN | |||||
| Contact: Contact Person 44-151-334-1155 | |||||
| Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting | ||||
| Brighton, England, United Kingdom, BN2 5BE | |||||
| Contact: Contact Person 44-12-7369-6955 | |||||
| Warrington Hospital NHS Trust | Recruiting | ||||
| Warrington, England, United Kingdom, WA5 1QG | |||||
| Contact: Contact Person 44-151-334-1155 | |||||
| Ipswich Hospital | Recruiting | ||||
| Ipswich, England, United Kingdom, IP4 5PD | |||||
| Contact: Contact Person 44-1473-704-177 | |||||
| Christie Hospital |
| Study Chair: | Catherine West | Christie Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000581139, CHNT-RAPPER, EU-20798 |
| First Received: | January 25, 2008 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00601406 |
| Health Authority: | Unspecified |
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