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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


N/A
40 Years
90 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion Criteria


- 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Stefan Ambs, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999905021

NCT ID:

NCT00342771

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Gene Expression
  • Genotype
  • Susceptibility
  • Race
  • Prostatic Neoplasms

Name

Location

University of Maryland Medical CenterBaltimore, Maryland  21201-1595
Baltimore Veterans Affairs Medical CenterBaltimore, Maryland