Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342771
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2006-06-19
Brief Title:
An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 220000 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
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
Detailed Description:
We are conducting an epidemiological prostate cancer case-control study in Baltimore Maryland Participants will be African American and Caucasian males who reside in Baltimore city and surrounding areas The study is ongoing and will recruit 1000 prostate cancer cases and 1000 population-based controls The cases are recruited at two Baltimore hospitals the Veterans Affairs Medical Center and the University of Maryland Center Cases will have pathologically confirmed prostate cancer The population-based controls are identified through the Maryland Department of Motor Vehicle Database and are frequency-matched by age and race to cases Enrollment of controls started concurrently with case accrual The first 12 months of the study constituted a pilot study during which we evaluated the recruitment procedures The study involves the administration of two questionnaires and collection of blood from all study subjects The two questionnaires consist of a main questionnaire and a supplemental questionnaire The questionnaires evaluate family cancer history tobacco use medication occupational history socioeconomic status and risk factors for prostate cancer Fresh-frozen tumor specimens will be obtained from cancer patients if available The study is supported by an epidemiological infrastructure that has been developed by our resource contractor at the University of Maryland for a lung cancer case-control study This lung cancer study is ongoing and the controls that are recruited for the prostate cancer study are joint controls with the lung cancer study Hence population-based male controls recruited by our contractor have double eligibility for the concurrent lung and prostate cancer studies To achieve an age and race matching of cases and controls in the prostate study we will over-sample male controls in the lung study
We will test the primary hypothesis that genes and environmental exposures including infections and medical history and interactions between those exposures and genetic factors modify prostate cancer susceptibility As the secondary goal we will study gene expression profiles of prostate tumors to identify changes in tumor biology that are associated with exposure to genetic and environmental risk factors It is a focus of this research to identify mechanisms in tumor biology that may cause the aggressive nature of prostate cancer in African American men
We will test the primary hypothesis that genes and environmental exposures including infections and medical history and interactions between those exposures and genetic factors modify prostate cancer susceptibility As the secondary goal we will study gene expression profiles of prostate tumors to identify changes in tumor biology that are associated with exposure to genetic and environmental risk factors It is a focus of this research to identify mechanisms in tumor biology that may cause the aggressive nature of prostate cancer in African American men
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-N021 | None | None | None |