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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00003329
First received: November 1, 1999
Last updated: April 2, 2013
Last verified: March 2008
  Purpose

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
Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Genetic: gene mapping

Study Type: Observational
Official Title: ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Estimated Enrollment: 4000
Study Start Date: January 1998
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003329

  Show 32 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
  More Information

Additional Information:
Publications:
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003329     History of Changes
Other Study ID Numbers: CDR0000066283, U10CA021115, ECOG-1Y97
Study First Received: November 1, 1999
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 26, 2014