Genetic Susceptibility to Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00848289
• Other study ID #: LAB98-040
• Secondary ID: LAB98-0405P50CA0
• Status: Recruiting
• Start date: February 10, 1998
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jian Gu, MD
• Phone: 713-792-3020
• Email: jiangu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Disease Susceptibility
• Genetic Predisposition to Disease
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   The University of Texas (UT) MD Anderson Cancer Center Official Website