Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6,086
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Participants with Bladder Cancer
Patients diagnosed with superficial or muscle-invasive bladder cancer. Specimens, personal and follow-up telephone interviews will be collected and conducted.
干预措施: Interviews (Behavioral)
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)