Genetic Susceptibility to Bladder Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | February 19, 2009 | ||||
| Last Updated Date | February 19, 2009 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To assess both cohorts, two mutagen sensitivity susceptibility assays that quantifies the number of lymphocytic chromatid breaks induced by in vitro exposure to bleomycin and the number of breaks induced by in vitro exposure to a tobacco carcinogen. [ Time Frame: After last subject has completed the study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetic Susceptibility to Bladder Cancer | ||||
| Official Title ICMJE | H-8577:Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach | ||||
| Brief Summary | Bladder cancer (BC) is a model disease system for evaluating the relationship of tobacco, dietary, and occupational exposures (which are responsible for up to 90% of BCs) and host-specific susceptibility factors. The induction of BC by arylamines (from tobacco or occupational exposure) is one of the best understood types of carcinogenesis. There is also substantial evidence suggesting that an individual's genetic make-up influences susceptibility to cancer. This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. We propose to conduct a case-control study examining interindividual differences in susceptibility to tobacco carcinogenesis as predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis and this will include studies of the genetic modulation of carcinogen activation and detoxification and of chromosome sensitivity to tobacco mutagens. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: blood (about 40 cc or 8 teaspoons), urine |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Any patient who have been diagnosed with bladder cancer or who is healthy is eligible to participate without regard to age, sex, or ethnicity. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Specimens, personal and follow-up telephone interviews
Specimens, personal and follow-up telephone interviews |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 2200 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00848289 | ||||
| Other Study ID Numbers ICMJE | H-8577, NCI | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Seth P. Lerner, MD, Baylor College of Medicine | ||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||
| Collaborators ICMJE | M.D. Anderson Cancer Center | ||||
| Investigators ICMJE |
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| Information Provided By | Baylor College of Medicine | ||||
| Verification Date | February 2009 | ||||
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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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