Status:
COMPLETED
An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40-90 years
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 pati...
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 a...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA
- CASE SUBJECT SELECTION
- We will recruit incident cases of pathologically confirmed PCa at all stages of the disease that are age 40 to 90 years. Treatment can be surgery or therapy. The following check list will be used to verify eligibility of a case subject.
- ELIGIBILITY CHECK LIST - PROSTATE CANCER CASES
- CRITERIA (ALL MUST BE CHECKED):
- Has been diagnosed with prostate cancer within the last two years
- Pathological diagnosis of prostate cancer made at the local hospital pathology department
- Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel and Prince George s counties, Eastern Shore, western and northern Maryland, or adjacent counties in Pennsylvania, Delaware, Virginia, or the Washington Metropolitan area
- Has a residential working phone within his home
- Born in the United States
- Of African-American or Caucasian descent, and age 40 to 90 years
- A non-objection statement by the physician from the hospital where the patient was identified, or listed as the treating physician by the tumor registry or surgical pathology report, to contact the patient
- Is not currently residing in an institution, such as a prison, nursing home, or shelter
- Is not a severely ill patient in the intensive care unit
- Speaks English well enough to be interviewed
- Is able to give informed consent
- Is physically and mentally capable of performing the interview
- Has never been interviewed as a control for this study
- Subject provides informed consent and signs form.
- Unwilling Unavailable
- SELECTION OF POPULATION-BASED CONTROLS
- Population-based controls will be identified through the Department of Motor Vehicles (DMV), and matched on age (5-year intervals), gender and race to cases. Recruitment of controls will start concurrently with case accrual, using the age and race frequency distribution of cancer patients in previous years, but recruitment objectives can be re-assessed to ensure a frequency-matched study. We will exclude controls that do not have a listed home phone number. The following check list will be used to verify eligibility of a control subject.
- ELIGIBILITY CHECK LIST - POPULATION-BASED CONTROLS
- CRITERIA (ALL MUST BE CHECKED):
- Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel and Prince George s counties, Eastern Shore, western and northern Maryland, or adjacent counties in Pennsylvania, Delaware, Virginia, or the Washington Metropolitan area
- Has a residential working phone within his home
- Born in the United States
- Of African-American or Caucasian descent, and age 40 to 90 years
- Does not have a personal history of cancer other than basal and non-melanomic skin cancer
- Have never had radiation therapy or chemotherapy
- Is not currently residing in an institution, such as a prison, nursing home, or shelter
- Speaks English well enough to be interviewed
- Is able to give informed consent
- Is physically and mentally capable of performing the interview
- Has never been interviewed as a control for the study
- Subject provides informed consent and signs form.
- Unwilling Unavailable
Exclusion
Key Trial Info
Start Date :
November 8 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2020
Estimated Enrollment :
2033 Patients enrolled
Trial Details
Trial ID
NCT00342771
Start Date
November 8 2004
End Date
August 6 2020
Last Update
August 14 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1595
2
VA Hospital, Baltimore
Baltimore, Maryland, United States