Prostate CancerNCT00342771
An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
An observational study of Prostate Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 2,033 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2004to 6 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.@@@@@@
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201-1595
VA Hospital, Baltimore
Baltimore, Maryland
About this study
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
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.
Read more
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.
...
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Tobacco Use, Tumor Biology, Biomarker, Risk Factor, Health Disparity
- Medical subject headings
- Prostatic Neoplasms, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NCI Maryland pop-based controls | population-based controls | |
| NCI-Maryland Prostate Cancer Cases | prostate cancer cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start8 Nov 2004
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stefan Ambs, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342771
- Sponsor's protocol ID
- 999905021
- Other IDs
- 05-C-N021
- Status last verified
- Aug 2020
- First submitted
- 19 Jun 2006
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12648986Roberts 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.
PubMed 12544299Hoffman 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.
PubMed 11238701
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00342771
- Acronym / sponsor ID
- 999905021
- Conditions
- Prostate Cancer
- Keywords
- Tobacco Use, Tumor Biology, Biomarker, Risk Factor, Health Disparity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,033 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 Nov 2004 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCI Maryland pop-based controls | – | –population-based controls |
| NCI-Maryland Prostate Cancer Cases | – | –prostate cancer cases |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.@@@@@@
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of risk factors
Time frame: After completion of recruitment
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
Identification of disease biomarkers
Time frame: Ongoing
association of blood and/or urine-based metabolites, and blood-based immune- inflammation markers with either ancestry, lifestyle factors, prostate cancer, and lethal disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Background: PubMed 12648986DeMarzo 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.
- Background: PubMed 12544299Roberts 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.
- Background: PubMed 11238701Hoffman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Ambs, Ph.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of risk factors (time frame: After completion of recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342771, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.