Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	November 1, 1999
Last Updated Date	February 6, 2009
Start Date ^ICMJE	January 1998
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00003329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer
Official Title ^ICMJE	ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci
Brief Summary	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.
Detailed Description	OBJECTIVES: Gather allele-sharing statistics at approximately 100 candidate loci throughout the human genome most likely to influence genetic risk of cancer. Use these allele-sharing statistics to test the interaction of each locus individually with cancer-associated, rare alleles of HRAS1. Generalize this approach for one of four cancers (breast, colon, lung, or prostate), using allele-sharing statistics to test the interaction of each locus with every other locus. Replicate positive results in a distinct set of sibling pairs with cancer. Examine, when loci contributing to risk are detected, the influence of this genetic background on clinical outcomes, such as survival. 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.)
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer
Intervention ^ICMJE	Genetic: gene mapping
Study Arms / Comparison Groups
Publications *	Larson GP, Ding Y, Cheng LS, Lundberg C, Gagalang V, Rivas G, Geller L, Weitzel J, MacDonald D, Archambeau J, Slater J, Neuberg D, Daly MB, Angel I, Benson AB 3rd, Smith K, Kirkwood JM, O'Dwyer PJ, Raskay B, Sutphen R, Drew R, Stewart JA, Werndli J, Johnson D, Ruckdeschel JC, Elston RC, Krontiris TG. Genetic linkage of prostate cancer risk to the chromosome 3 region bearing FHIT. Cancer Res. 2005 Feb 1;65(3):805-14.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	4000
Completion Date
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	DISEASE CHARACTERISTICS: Histologically confirmed colon, lung, prostate, or invasive breast cancer No ductal or lobular carcinoma in situ of the breast only Patient and natural full sibling must have (or have had) cancer of the same type Participants in E-3Y92 not eligible Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00003329
Responsible Party
Study ID Numbers ^ICMJE	CDR0000066283, ECOG-1Y97
Study Sponsor ^ICMJE	Eastern Cooperative Oncology Group
Collaborators ^ICMJE	National Cancer Institute (NCI)
Investigators ^ICMJE
Information Provided By	National Cancer Institute (NCI)
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP