Prostate CancerNCT00342784
Identification of Prostate Cancer Genes
An observational study of Prostate Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will identify genes that predispose men to prostate cancer and affect the rate and type of disease spread, the aggressiveness of the disease, and the long-term outcome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prostate Cancer
- How many people
- 5,118 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2004to 30 Jul 2018
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study families were required to meet at least one of the following criteria:
- Have three or more first-degree relatives with PC
- Have three generations with PC, either through paternal or maternal lineage; or
- Have two-first degree relatives with PC diagnosed before age 65 or who were African American. All surviving men, and selected unaffected men and females were invited to join.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Genetic Analysis of Cases, Controls, and Families With Prostate Cancer
This study will identify genes that predispose men to prostate cancer and affect the rate and type of disease spread, the aggressiveness of the disease, and the long-term outcome. Several studies show there is a genetic component to prostate cancer susceptibility, and that a first-degree relative with prostate cancer increases a man's risk 2- to 3-fold compared to those without a family history. The risk is significantly higher if the relative was diagnosed at younger than 65 years of age, or if three or more first-degree relatives are affected.
The study will try to locate prostate cancer genes in DNA samples using two methods: linkage analysis and association studies. Traditionally, the search for a disease gene begins with linkage analysis, in which the aim is to find the rough location of the gene relative to another DNA sequence, called a "genetic marker," whose position is already known. In genetic association studies, genes from a large number of patients are compared with healthy controls who are matched by age, race, and geographic region.
Read more
DNA samples for this study come from patients in the two following studies at the Fred Hutchinson Cancer Research Center, Seattle, Washington:
Family study: Participants are families with prostate cancer who have: 1) three or more first-degree relatives with prostate cancer; 2) three generations with prostrate cancer either through the maternal or paternal side of the family; or 3) two first-degree relatives with prostate cancer diagnosed before age 65 or who were African American.
Population-based study: Participants are patients with prostate cancer and matched healthy control subjects.
The identification of prostate cancer genes important in susceptibility to the disease and its aggressiveness may permit earlier detection and development of more directed and effective treatments based on underlying genetics.
Read the detailed description
The notion that there are prostate cancer susceptibility genes has since been suggested by case-control, cohort and twin studies. The effect is strongest among first-degree relatives, where the relative risk estimates range from 1.7 to 3.7. Families reporting younger ages at diagnosis and multiple relatives with prostate cancer were demonstrated even higher relative risks. For example, compared to men with no family history, men with three or more first-degree relatives with prostate cancer have almost an 11-fold increased risk. Although the majority of studies focused on Caucasians, similar elevations in risk associated with a family history of disease have been reported for Asian and African Americans. While the majority of the data seems to point towards autosomal dominant genes, evidence for an X-linked or recessive inheritance has also been reported.
During the last decade, others and we have been devoted to the search for hereditary prostate cancer (HPC) loci either by linkage or by association with candidate genes. A generally agreed upon definition of HPC families now exists. These are families in which there is either: 1) prostate cancer in three or more first-degree relatives; 2) prostate cancer in three successive generations; or 3) a cluster of two relatives diagnosed at less than or equal to 55 years.
Armed with these criteria, others and we have collected large data sets of likely hereditary families and undertaken genome wide scans. However, locus heterogeneity issues have made the task difficult. There are clearly many genes that contribute to prostate cancer susceptibility, and many are likely to be weakly penetrant. We have stratified the data derived from our genome scan by a number of likely factors such as age at diagnosis, number of affected men, founder effects aggressiveness of disease, and presence of other cancers in the family to develop more homogeneous datasets. We propose to continue those sorts of studies, as well as focus on cloning genes in regions we and others have identified to date. To test hypotheses that certain variants are associated with prostate cancer susceptibility or progression of disease, will also conduct association studies in a population-based, case control study of middle aged men with prostate cancer. This will allow us to test the putative association of candidate genes and SNPs in prostate cancer susceptibility, aggressivity, and long-term outcomes.
- Conditions
- Prostate Cancer
- Keywords
- Mutation, Cancer Genetics
- Medical subject headings
- Prostatic Neoplasms
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
- Study completion30 Jul 2018
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.
- 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
- Enrolment
- 5,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elaine A Ostrander, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342784
- Sponsor's protocol ID
- 999905034
- Other IDs
- 05-HG-N034
- Status last verified
- 30 Jul 2018
- First submitted
- 19 Jun 2006
- Last updated
- 1 Aug 2018
- Results posted
- No
Publications
Fincham SM, Hill GB, Hanson J, Wijayasinghe C. Epidemiology of prostatic cancer: a case-control study. Prostate. 1990;17(3):189-206. doi: 10.1002/pros.2990170303.
PubMed 2235728Steinberg GD, Carter BS, Beaty TH, Childs B, Walsh PC. Family history and the risk of prostate cancer. Prostate. 1990;17(4):337-47. doi: 10.1002/pros.2990170409.
PubMed 2251225Hayes RB, Liff JM, Pottern LM, Greenberg RS, Schoenberg JB, Schwartz AG, Swanson GM, Silverman DT, Brown LM, Hoover RN, et al. Prostate cancer risk in U.S. blacks and whites with a family history of cancer. Int J Cancer. 1995 Jan 27;60(3):361-4. doi: 10.1002/ijc.2910600315.
PubMed 7829245
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Cases, Controls, and Families With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00342784
- Acronym / sponsor ID
- 999905034
- Conditions
- Prostate Cancer
- Keywords
- Mutation, Cancer Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,118 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 8 Nov 2004
- Study completion
- 30 Jul 2018
- 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 identify genes that predispose men to prostate cancer and affect the rate and type of disease spread, the aggressiveness of the disease, and the long-term outcome. Several studies show there is a genetic component to prostate cancer susceptibility, and that a first-degree relative with prostate cancer increases a man's risk 2- to 3-fold compared to those without a family history. The risk is significantly higher if the relative was diagnosed at younger than 65 years of age, or if three or more first-degree relatives are affected.
The study will try to locate prostate cancer genes in DNA samples using two methods: linkage analysis and association studies. Traditionally, the search for a disease gene begins with linkage analysis, in which the aim is to find the rough location of the gene relative to another DNA sequence, called a "genetic marker," whose position is already known. In genetic association studies, genes from a large number of patients are compared with healthy controls who are matched by age, race, and geographic region.
DNA samples for this study come from patients in the two following studies at the Fred Hutchinson Cancer Research Center, Seattle, Washington:
Family study: Participants are families with prostate cancer who have: 1) three or more first-degree relatives with prostate cancer; 2) three generations with prostrate cancer either through the maternal or paternal side of the family; or 3) two first-degree relatives with prostate cancer diagnosed before age 65 or who were African American.
Population-based study: Participants are patients with prostate cancer and matched healthy control subjects.
The identification of prostate cancer genes important in susceptibility to the disease and its aggressiveness may permit earlier detection and development of more directed and effective treatments based on underlying genetics.
Detailed description
The notion that there are prostate cancer susceptibility genes has since been suggested by case-control, cohort and twin studies. The effect is strongest among first-degree relatives, where the relative risk estimates range from 1.7 to 3.7. Families reporting younger ages at diagnosis and multiple relatives with prostate cancer were demonstrated even higher relative risks. For example, compared to men with no family history, men with three or more first-degree relatives with prostate cancer have almost an 11-fold increased risk. Although the majority of studies focused on Caucasians, similar elevations in risk associated with a family history of disease have been reported for Asian and African Americans. While the majority of the data seems to point towards autosomal dominant genes, evidence for an X-linked or recessive inheritance has also been reported.
During the last decade, others and we have been devoted to the search for hereditary prostate cancer (HPC) loci either by linkage or by association with candidate genes. A generally agreed upon definition of HPC families now exists. These are families in which there is either: 1) prostate cancer in three or more first-degree relatives; 2) prostate cancer in three successive generations; or 3) a cluster of two relatives diagnosed at less than or equal to 55 years.
Armed with these criteria, others and we have collected large data sets of likely hereditary families and undertaken genome wide scans. However, locus heterogeneity issues have made the task difficult. There are clearly many genes that contribute to prostate cancer susceptibility, and many are likely to be weakly penetrant. We have stratified the data derived from our genome scan by a number of likely factors such as age at diagnosis, number of affected men, founder effects aggressiveness of disease, and presence of other cancers in the family to develop more homogeneous datasets. We propose to continue those sorts of studies, as well as focus on cloning genes in regions we and others have identified to date. To test hypotheses that certain variants are associated with prostate cancer susceptibility or progression of disease, will also conduct association studies in a population-based, case control study of middle aged men with prostate cancer. This will allow us to test the putative association of candidate genes and SNPs in prostate cancer susceptibility, aggressivity, and long-term outcomes.
Study design
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have three or more first-degree relatives with PC
- Have three generations with PC, either through paternal or maternal lineage; or
- Have two-first degree relatives with PC diagnosed before age 65 or who were African American. All surviving men, and selected unaffected men and females were invited to join.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 1 Aug 2018.
- Background: PubMed 2235728Fincham SM, Hill GB, Hanson J, Wijayasinghe C. Epidemiology of prostatic cancer: a case-control study. Prostate. 1990;17(3):189-206. doi: 10.1002/pros.2990170303.
- Background: PubMed 2251225Steinberg GD, Carter BS, Beaty TH, Childs B, Walsh PC. Family history and the risk of prostate cancer. Prostate. 1990;17(4):337-47. doi: 10.1002/pros.2990170409.
- Background: PubMed 7829245Hayes RB, Liff JM, Pottern LM, Greenberg RS, Schoenberg JB, Schwartz AG, Swanson GM, Silverman DT, Brown LM, Hoover RN, et al. Prostate cancer risk in U.S. blacks and whites with a family history of cancer. Int J Cancer. 1995 Jan 27;60(3):361-4. doi: 10.1002/ijc.2910600315.
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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.
Elaine A Ostrander, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site 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 Human Genome Research Institute (NHGRI) at 1 site 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?
The sponsor lists 4 inclusion and 0 exclusion criteria. 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342784, 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 1 Aug 2018.