An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 90 |
| Updated: | 9/22/2018 |
| Start Date: | November 8, 2004 |
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
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.
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.
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.
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.
- 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
We found this trial at
2
sites
22 S Greene St
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-5512
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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