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

Breast Cancer Clinical Trial

Official title:

ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003329
• Other study ID #: CDR0000066283
• Secondary ID: U10CA021115ECOG-
• Status: Completed
• Start date: April 7, 1998

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Lung Cancer
• Lung Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• gene mapping

Locations

Country	Name	City	State
United States	Fox Valley Hematology and Oncology - East Grant Street	Appleton	Wisconsin
United States	Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital	Boca Raton	Florida
United States	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois
United States	Finger Lakes Hematology and Oncology	Clifton Springs	New York
United States	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Dickinson County Healthcare System	Iron Mountain	Michigan
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin
United States	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin
United States	Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center	Rancho Mirage	California
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Jennersville Regional Hospital	West Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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, Johns — View Citation