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

NCT ID: NCT00003329

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-04-07

Brief Summary

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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

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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.)

Conditions

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Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer

Interventions

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gene mapping

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

0 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center

Rancho Mirage, California, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital

Boca Raton, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, United States

Site Status

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, United States

Site Status

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States

Site Status

Dickinson County Healthcare System

Iron Mountain, Michigan, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, United States

Site Status

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, United States

Site Status

Finger Lakes Hematology and Oncology

Clifton Springs, New York, United States

Site Status

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Site Status

Jennersville Regional Hospital

West Grove, Pennsylvania, United States

Site Status

Fox Valley Hematology and Oncology - East Grant Street

Appleton, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

Site Status

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 15705877 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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U10CA021115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ECOG-1Y97

Identifier Type: -

Identifier Source: secondary_id

CDR0000066283

Identifier Type: -

Identifier Source: org_study_id

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