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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003329 |
RATIONALE: Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a person's risk of getting cancer.
PURPOSE: This clinical trial is studying to see if certain genes may be associated with cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these patients.
Condition | Intervention |
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Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer |
Genetic: gene mapping |
Study Type: | Observational |
Official Title: | ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci |
Estimated Enrollment: | 4000 |
Study Start Date: | January 1998 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Each patient-sibling pair completes a family history questionnaire about the incidence of cancer in the family. Blood samples are obtained from both the patient and the sibling (and both living parents, if available).
The blood samples are genotyped using approximately 300 micro-satellite markers flanking 100 candidate genes previously implicated in genetic risk for cancer. Certain loci are a priority due to their association with HRAS1: BRCA1 and all known mismatch repair loci; other repair genes, such as ATM; the Bloom's syndrome locus; and the XRCC group. Other genes are also mapped.
Patients do not receive the results of the genetic testing and the results do not influence the type and duration of treatment.
Patients only are followed annually.
PROJECTED ACCRUAL: This study will accrue 1,000 patient-sibling pairs for breast cancer. After 18 months, another 1,000 patient-sibling pairs will be accrued for breast cancer. Therefore, up to 2,000 patient-sibling pairs will be accrued over 5 years. (Feasibility of accruing pairs for lung, colon, and prostate cancer is being assessed.)
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colon, lung, prostate, or invasive breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study ID Numbers: | CDR0000066283, ECOG-1Y97 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003329 History of Changes |
Health Authority: | United States: Federal Government |
stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
stage I non-small cell lung cancer stage II non-small cell lung cancer stage III non-small cell lung cancer limited stage small cell lung cancer extensive stage small cell lung cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Rectal Diseases Respiratory Tract Diseases Lung Neoplasms Genetic Predisposition to Disease Breast Diseases Digestive System Neoplasms Skin Diseases |
Disease Susceptibility Breast Neoplasms Intestinal Diseases Genital Diseases, Male Intestinal Neoplasms Carcinoma, Small Cell Digestive System Diseases Lung Diseases Non-small Cell Lung Cancer Gastrointestinal Neoplasms Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms Colorectal Neoplasms |
Thoracic Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Prostatic Diseases Genital Neoplasms, Male Skin Diseases Gastrointestinal Diseases Colonic Diseases Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Respiratory Tract Diseases Lung Neoplasms Lung Diseases Gastrointestinal Neoplasms Prostatic Neoplasms Colorectal Neoplasms Breast Diseases |