Clinical trial NCT00848289: Genetic Susceptibility to Bladder Cancer
Official title: Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bladder Cancer
Keywords: Bladder cancer
Genetic susceptibility
Increased Risk
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-20
Enrollment: 6086
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who have been diagnosed with bladder cancer or who is healthy is eligible to participate without regard to age, sex, or ethnicity.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: After last subject has completed the study, up to 5 years
Secondary outcomes:
measure: Frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smoke
timeFrame: After the last subject completes the study, up to 5 years
measure: 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
timeFrame: After the last subject has completed the study, up to 5 years per individual participation
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jian Gu, MD
role: PRINCIPAL_INVESTIGATOR
References: