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Sponsored by: |
Christie Hospital NHS Foundation Trust |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601406 |
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 |
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Breast Cancer Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Prostate Cancer Sarcoma Vaginal Cancer Vulvar Cancer |
Genetic: gene expression analysis Genetic: gene rearrangement analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Radiation: radiation therapy |
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.
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:
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 |
Study Chair: | Catherine West | Christie Hospital NHS Foundation Trust |
Study ID Numbers: | CDR0000581139, CHNT-RAPPER, EU-20798 |
Study First Received: | January 25, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00601406 History of Changes |
Health Authority: | Unspecified |
male breast cancer stage I breast cancer stage II breast cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer stage I uterine sarcoma stage II uterine sarcoma |
stage III uterine sarcoma stage IV uterine sarcoma fallopian tube cancer stage I vaginal cancer stage II vaginal cancer stage III vaginal cancer stage IVA vaginal cancer stage IVB vaginal cancer stage I vulvar cancer stage II vulvar cancer stage III vulvar cancer stage IV vulvar cancer stage I ovarian epithelial cancer stage I ovarian germ cell tumor stage II ovarian epithelial cancer |
Fallopian Tube Cancer Genital Neoplasms, Male Prostatic Diseases Gonadal Disorders Vulvar Cancer Vaginal Cancer Endometrial Cancer Urogenital Neoplasms Vaginal Diseases Breast Cancer, Male Ovarian Diseases Genital Diseases, Female Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Endometrial Neoplasms |
Vulvar Neoplasms Ovarian Cancer Uterine Neoplasms Breast Diseases Endocrine Gland Neoplasms Vaginal Neoplasms Ovarian Neoplasms Skin Diseases Genital Neoplasms, Female Uterine Diseases Breast Neoplasms Endocrine System Diseases Ovarian Epithelial Cancer Genital Diseases, Male Fallopian Tube Neoplasms |
Genital Neoplasms, Male Prostatic Diseases Gonadal Disorders Urogenital Neoplasms Vaginal Diseases Ovarian Diseases Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplasms by Site Vulvar Neoplasms Uterine Neoplasms Breast Diseases Endocrine Gland Neoplasms Vaginal Neoplasms |
Neoplasms by Histologic Type Ovarian Neoplasms Skin Diseases Genital Neoplasms, Female Uterine Diseases Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Fallopian Tube Neoplasms Fallopian Tube Diseases Adnexal Diseases Neoplasms Sarcoma Prostatic Neoplasms Vulvar Diseases |