Genetic Susceptibility to Bladder Cancer

Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Behavioral: Interviews

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 Type: Observational
• Enrollment (Actual): 6086

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Md Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Interviews; Data collected by personal interview for Epidemiology and Nutrition Questionnaires, with personal and follow-up telephone interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jian Gu, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 1998
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 19, 2009
• First Submitted That Met QC Criteria: February 19, 2009
• First Posted (Estimated): February 20, 2009

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Bladder cancer; Genetic susceptibility; Increased Risk
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Urologic Neoplasms; Urinary Bladder Diseases; Disease Susceptibility; Pathological Conditions, Signs and Symptoms; Urinary Bladder Neoplasms; Genetic Predisposition to Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: LAB98-040 (Other Identifier: MD Anderson Cancer Center); 5P50CA091846-14 (U.S. NIH Grant/Contract); H-8577 (Other Identifier: Baylor College of Medicine); 5R01CA074880 (U.S. NIH Grant/Contract); NCI-2021-06405 (Other Identifier: Clinical Trials Reporting Program (CTRP))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No