Clinical Trial: Genetic Susceptibility to Bladder Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach

Brief Summary: This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. Researchers 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.

Detailed Summary: Researchers 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.
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Comparison of 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, up to 5 years ]

Mutagen sensitivity as measured by quantifying the number of lymphocytic chromatid breaks and comet tail moments induced by in vitro exposure to bleomycin (a radiomimetic agent) and benzo[a]pyrene diol epoxide (BPDE, a tobacco carcinogen) in bladder cancer cases in comparison to data for controls


Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • Frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smoke [ Time Frame: After the last subject completes the study, up to 5 years ]
  • Associations between the cytogenetic, molecular components and epidemiologic covariates (age, sex, ethnicity, cigarette smoking status, alcohol use, dietary intake, and family history of cancer) in risk of bladder cancer [ Time Frame: After the last subject has completed the study, up to 5 years per individiual participation ]


Original Secondary Outcome:

  • To determine in both cohorts, the frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smoke. [ Time Frame: After the last subject completes the study ]
  • To explore the associations between the cytogenetic, molecular components and epidemiologic covariates (age, sex, ethnicity, cigarette smoking status, alcohol use, dietary intake, and family history of cancer) in risk of bladder cancer. [ Time Frame: After the last subject has completed the study ]


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: February 19, 2009
Date Started: February 10, 1998
Date Completion: August 2018
Last Updated: April 24, 2017
Last Verified: April 2017