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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003329
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 4, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment
Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Genetic: gene mapping

Detailed Description:


  • 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 Type : Observational
Estimated Enrollment : 4000 participants
Official Title: ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci
Study Start Date : January 1998
Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003329

  Show 32 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003329     History of Changes
Other Study ID Numbers: CDR0000066283
U10CA021115 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: March 2008

Keywords provided by Eastern Cooperative Oncology Group:
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

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases