Genetic Susceptibility to Bladder Cancer

N/AActive Not RecruitingNCT00848289

M.D. Anderson Cancer Center6,086 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

6,086

Conditions

Bladder Cancer

Interventions

InterviewsBEHAVIORAL

Data collected by personal interview for Epidemiology and Nutrition Questionnaires, with personal and follow-up telephone interviews.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has a histologically confirmed diagnosis of superficial or muscle-invasive bladder cancer * Subject is a Texas resident. * Subject can understand English or a qualified translator is available for the interview. * Subjects of any age, gender, or ethnicity are eligible to participate in the study. * Subject consents to participate in the study. Exclusion Criteria: * Subject has had prior treatment with systemic chemotherapy or radiotherapy in the past 6 months. * Subject has been diagnosed with superficial or muscle-invasive bladder cancer more than twelve months ago.

Locations (2)

Baylor College of Medicine

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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

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

Time frame: After last subject has completed the study, up to 5 years

Secondary Outcomes

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 individual participation

Data from ClinicalTrials.gov

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