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Sponsors and Collaborators: |
Baylor College of Medicine M.D. Anderson Cancer Center |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00848289 |
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.
Condition | Intervention |
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Bladder Cancer Healthy |
Other: Specimens, personal and follow-up telephone interviews |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | H-8577:Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach |
blood (about 40 cc or 8 teaspoons), urine
Estimated Enrollment: | 2200 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients with bladder cancer.
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Other: Specimens, personal and follow-up telephone interviews
Specimens, personal and follow-up telephone interviews
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2
Healthy patients
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Other: Specimens, personal and follow-up telephone interviews
Specimens, personal and follow-up telephone interviews
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Any patient who have been diagnosed with bladder cancer or who is healthy is eligible to participate without regard to age, sex, or ethnicity.
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan L. Kingston, LVN, CCRP | 713-798-8514 | slk@bcm.edu |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Susan L. Kingston, LVN, CCRP 713-798-8514 slk@bcm.edu | |
Principal Investigator: Seth P. Lerner, MD | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: XIFENG WU, MD 713-792-0807 xwu@mdanderson.org |
Principal Investigator: | Seth P. Lerner, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Seth P. Lerner, MD ) |
Study ID Numbers: | H-8577, NCI |
Study First Received: | February 19, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848289 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bladder cancer Genetic susceptibility Increased Risk |
Urinary Tract Neoplasm Cystocele Urologic Diseases Disease Susceptibility Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Healthy Bladder Neoplasm Genetic Predisposition to Disease Urologic Neoplasms |
Disease Attributes Neoplasms Pathologic Processes Neoplasms by Site Urologic Diseases Disease Susceptibility |
Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Genetic Predisposition to Disease Urologic Neoplasms |