Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Genetics Completed Not specified NCI ECOG-1Y97 E1Y97, NCT00003329

Objectives

1. Gather allele-sharing statistics at approximately 100 candidate loci throughout the human genome most likely to influence genetic risk of cancer.
2. Use these allele-sharing statistics to test the interaction of each locus individually with cancer-associated, rare alleles of HRAS1.
3. 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.
4. Replicate positive results in a distinct set of sibling pairs with cancer.
5. Examine, when loci contributing to risk are detected, the influence of this genetic background on clinical outcomes, such as survival.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• 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

Expected Enrollment

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.)

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.

Larson GP, Ding Y, Cheng LS, et al.: Genetic linkage of prostate cancer risk to the chromosome 3 region bearing FHIT. Cancer Res 65 (3): 805-14, 2005.[PUBMED Abstract]

Krontiris TG, Larson M, Weitzel JN, et al.: Mapping interactive cancer susceptibility loci: Eastern Cooperative Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A2147, 560a, 1998.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Clinical Trials Office - New Patient Services		Ph: 800-826-4673 Email: becomingapatient@coh.org

Registry Information
Official Title		ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci
Trial Start Date		1998-01-30
Trial Completion Date		2007-12-27
Registered in ClinicalTrials.gov		NCT00003329
Date Submitted to PDQ		1998-02-11
Information Last Verified		2008-03-06
NCI Grant/Contract Number		CA21115