Diet, Genetic Variation and Prostate Cancer Among African Americans
This study has been completed.
Sponsor:
University of California, Davis
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584792
First received: December 22, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2007 | ||||
| Last Updated Date | December 22, 2007 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Is there a difference in ancestry percentage between the controls (no cancer) and the cases (prostate cancer) [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diet, Genetic Variation and Prostate Cancer Among African Americans | ||||
| Official Title ICMJE | Diet, Genetic Variation and Prostate Cancer Among African Americans | ||||
| Brief Summary | This is a single center pilot study to asses the feasibility of conducting a larger population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer Center's Development Award Program. The hypothesis is that the percent african ancestry in an individual may determine their prognosis if diagnosed with prostate cancer. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Serum collected for Ancestry Imformative Markers (AIMS) testing along with PSA and CRP. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | African American males between the ages of 35 and 75. |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 102 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Self-identification as a male with African ancestry Between ages of 35-75 Exclusion Criteria: No African ancestry Not between ages of 35-75 - |
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| Gender | Male | ||||
| Ages | 35 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00584792 | ||||
| Other Study ID Numbers ICMJE | 200614379, AA Pilot Study | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lesley Butler, PhD, University of California, Davis | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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