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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
Sponsor study identifier
Secondary identifiers
observational
2,033
1 country
2
Study Start
November 8, 2004
Actual (reported)Primary Completion
August 6, 2020
Actual (reported)Study Completion
August 6, 2020
Actual (reported)This study will examine the association of genetic variants and gene expression patterns with the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA from 600 patients with the disease and from 600 healthy people, and there will be a gene expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men in Western countries. It is estimated that 220,000 or more new cases of the disease will occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger than age 40. There are large differences in incidence by geography and race. The highest rates are seen among African-American men in the United States. Also, although Caucasians have a lower rate of disease incidence and mortality in the United States, the rates among them are high compared with rates in some European countries. The reasons for such differences are not well understood, but both environmental and genetic risk factors are thought to be involved. Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months, who reside in Baltimore City or adjacent metropolitan counties, and who were born in the United States may be eligible for this study. They will be recruited in collaboration with the Departments of Pathology and Urology at the University of Maryland and the Baltimore Veterans Affairs Medical Center. Those men serving as controls in this study will be identified through the Department of Motor Vehicles database and will be matched by age and race with the patients who have cancer. The study will include 600 participants with prostate cancer and 600 participants in the control group. Trained interviewers will administer two questionnaires. The primary questionnaire will be used to assess information such as medical and cancer history, tobacco use, current medications, occupational history, family medical history, and socioeconomic status. A supplemental questionnaire will pertain to patients' exposure to risk factors for prostate cancer. It will assess the human body, diet, medical history, family medical history, and sexual history. The section on sexual history will be self-administered. Patients will undergo collection of blood and urine for various tests. For cancer patients with prostate surgery, there will also be a collection of tissue, to be performed at the time that the prostate gland is scheduled for surgical removal. The pattern of gene expression will be analyzed in low- and high-stage tumors. There will be no direct benefit from participating in the study, but participants will receive an incentive of up to $75 to participate in the study. No form of treatment is involved in this study. However, it is hoped that the study findings will improve researchers' understanding of prostate cancer biology with respect to the causes of the health variances between African-Americans and Caucasians. ...
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 6, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2004
Actual (reported)June 19, 2006
Actual (reported)June 21, 2006
Actual (reported)August 6, 2020
Actual (reported)August 6, 2020
Actual (reported)Identification of risk factors
association of tobacco use, obesity, inflammation and anti- inflammatory drugs, sexual activity and sexually transmitted diseases, and ancestral markers with prostate cancer and lethal disease
After completion of recruitment
Identification of disease biomarkers
association of blood and/or urine-based metabolites, and blood-based immune- inflammation markers with either ancestry, lifestyle factors, prostate cancer, and lethal disease.
Ongoing
population-based controls
prostate cancer cases
The study is a case-control study with a clinical and a community component. Participants are African- American and Caucasian males who resided in Baltimore city and surrounding areas. The cases were recruited at two Baltimore hospitals, the Veterans Affairs Medical Center and the University of Maryland Medical Center. Cases had pathologically confirmed prostate cancer. The population-based controls were identified through the Maryland Department of Motor Vehicle database.@@@@@@
University of Maryland Medical Center
Baltimore, Maryland, 21201-1595, United States
VA Hospital, Baltimore
Baltimore, Maryland, United States
DeMarzo AM, Nelson WG, Isaacs WB, Epstein JI. Pathological and molecular aspects of prostate cancer. Lancet. 2003 Mar 15;361(9361):955-64. doi: 10.1016/S0140-6736(03)12779-1.
Roberts WW, Platz EA, Walsh PC. Association of cigarette smoking with extraprostatic prostate cancer in young men. J Urol. 2003 Feb;169(2):512-6; discussion 516. doi: 10.1097/01.ju.0000046160.80804.7f.
Hoffman RM, Gilliland FD, Eley JW, Harlan LC, Stephenson RA, Stanford JL, Albertson PC, Hamilton AS, Hunt WC, Potosky AL. Racial and ethnic differences in advanced-stage prostate cancer: the Prostate Cancer Outcomes Study. J Natl Cancer Inst. 2001 Mar 7;93(5):388-95. doi: 10.1093/jnci/93.5.388.
Stefan Ambs, Ph.D.
National Cancer Institute (NCI)
2,033 participants (actual enrollment reported by the registry).
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
November 8, 2004
Actual (reported)Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Primary Completion
August 6, 2020
Actual (reported)Study Completion
August 6, 2020
Actual (reported)Last Updated
August 14, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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