Genetic and Environmental Risk Factors in African American and Caucasian Healthy Men and in Patients With Prostate Cancer - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00556725

Purpose

RATIONALE: Gathering information about genetic and environmental factors may help doctors understand why African American men have an increased risk of prostate cancer and die more often from prostate cancer than Caucasian men.

PURPOSE: This clinical trial is studying genetic and environmental risk factors in African American and Caucasian healthy men and in patients with prostate cancer.

Condition	Intervention
Prostate Cancer	Procedure: evaluation of cancer risk factors Procedure: gene expression analysis Procedure: molecular genetic technique Procedure: questionnaire administration Procedure: study of socioeconomic and demographic variables

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Case-Control Study of Prostate Cancer in the Greater Baltimore Area: An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Genetic and environmental factors that predispose African-American males to a higher prostate cancer incidence and mortality than Caucasians

Estimated Enrollment:	1200
Study Start Date:	October 2004

Detailed Description:

OBJECTIVES:

Primary

To identify genetic and environmental factors that predispose African-American males to a higher prostate cancer incidence and mortality than Caucasians.

OUTLINE: This is a multicenter study.

All patients and healthy participants undergo collection of blood or mouth cells and urine. Patients who undergo prostatectomy donate a sample of ther tumor for genotype, gene expression, and protein expression analysis. Family cancer history, medical history, human body, tobacco and alcohol use, medication, occupational history, lifestyle, sexual history, diet, socioeconomic status, and additional risk factors are assessed using questionnaires periodically.

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed prostate cancer diagnosed within the past 2 years (patients)
Identified through the Department of Motor Vehicle database (healthy participants)
Matched by age (5-year intervals), gender, and race to patients (healthy participants)
Self-identified African-American and Caucasian males aged 40 to 90 years old who reside in Baltimore City and surrounding areas including Western Maryland, Washington DC, Virginia, West Virginia, Delaware, and Pennsylvania (patients and healthy participants)
Eligible for lung cancer case-control study (patients and healthy participants)

PATIENT CHARACTERISTICS:

A non-objective statement to contact the patient must have been obtained from the treating physician at the hospital where the patient was identified or from a physician who is listed as the treating physician by the tumor registry or surgical pathology report (patients)
Never been interviewed as a control for the study (patients)
Never been interviewed as a control for the study (with the study protocol tracking database) (healthy participants)
Must have a residential working phone within the home (patients and healthy participants)
Must have been born in the United States (patients and healthy participants)
Must speak English well enough to be interviewed (patients and healthy participants)
Physically and mentally capable of performing the interview (patients and healthy participants)
No severely ill patients in the intensive care unit (may be reconsidered as eligible after discharge from intensive care unit) (patients)
No diagnosis of HIV, hepatitis B, or hepatitis C (patients)
No personal history of cancer other than basal cell or nonmelanoma skin cancer (healthy participants)
Not currently residing in an institution such as a prison, nursing home, or shelter (patients and healthy participants)
Able to give informed consent (patients and healthy participants)

PRIOR CONCURRENT THERAPY:

No prior radiation therapy or chemotherapy (healthy participants)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556725

Locations

United States, Maryland
University of Maryland School of Medicine	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Dean L. Mann, MD 410-328-5512
Veterans Affairs Medical Center - Baltimore	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Dean L. Mann, MD 410-328-5512

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Stefan Ambs, PhD

National Cancer Institute (NCI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000555293, NCI-05-C-N021
Study First Received:	November 9, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00556725
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

prostate cancer
adenocarcinoma of the prostate
stage I prostate cancer

stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Healthy

Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009