Genetic Susceptibility to Bladder Cancer

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Behavioral: Interviews


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Bladder Cancer<br>Patients diagnosed with superficial or muscle-invasive bladder cancer. Specimens, personal and follow-up telephone interviews will be collected and conducted. | Behavioral: Interviews<br>* Data collected by personal interview for Epidemiology and Nutrition Questionnaires, with personal and follow-up telephone interviews.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After last subject has completed the study, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smoke |  | 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 |  | After the last subject has completed the study, up to 5 years per individual participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, Genetic susceptibility, Increased Risk