Genetic Susceptibility to Bladder Cancer

Active, not recruiting

• Conditions: Bladder Cancer
• Interventions: Behavioral: Interviews

• Registration Number: NCT00848289
• Lead Sponsor: M.D. Anderson Cancer Center

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 Description

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 Timeline

• Study Start: 1998-02-10
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6086

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Bladder Cancer	Interviews	Patients diagnosed with superficial or muscle-invasive bladder cancer. Specimens, personal and follow-up telephone interviews will be collected and conducted.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States