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Genetic Susceptibility to Bladder Cancer

Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00848289
Enrollment
6086
Registered
2009-02-20
Start date
1998-02-10
Completion date
2026-08-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Bladder cancer, Genetic susceptibility, Increased Risk

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.

Interventions

BEHAVIORALInterviews

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

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 carcinogenAfter last subject has completed the study, up to 5 yearsMutagen 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

MeasureTime frame
Frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smokeAfter 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 cancerAfter the last subject has completed the study, up to 5 years per individual participation

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJian Gu, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026