Genetic Susceptibility to Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00848289
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 19, 2009
February 19, 2009
July 2008
June 2013   (final data collection date for primary outcome measure)
To assess both cohorts, two 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. [ Time Frame: After last subject has completed the study ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • To determine in both cohorts, the frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smoke. [ Time Frame: After the last subject completes the study ] [ Designated as safety issue: No ]
  • To explore the 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. [ Time Frame: After the last subject has completed the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Genetic Susceptibility to Bladder Cancer
H-8577:Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach

Bladder cancer (BC) is a model disease system for evaluating the relationship of tobacco, dietary, and occupational exposures (which are responsible for up to 90% of BCs) and host-specific susceptibility factors. The induction of BC by arylamines (from tobacco or occupational exposure) is one of the best understood types of carcinogenesis. There is also substantial evidence suggesting that an individual's genetic make-up influences susceptibility to cancer.

This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. We 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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood (about 40 cc or 8 teaspoons), urine

Non-Probability Sample

Any patient who have been diagnosed with bladder cancer or who is healthy is eligible to participate without regard to age, sex, or ethnicity.

  • Bladder Cancer
  • Healthy
Other: Specimens, personal and follow-up telephone interviews
Specimens, personal and follow-up telephone interviews
  • 1
    Patients with bladder cancer.
    Intervention: Other: Specimens, personal and follow-up telephone interviews
  • 2
    Healthy patients
    Intervention: Other: Specimens, personal and follow-up telephone interviews
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2200
January 2014
June 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Susan L. Kingston, LVN, CCRP 713-798-8514 slk@bcm.edu
United States
 
NCT00848289
H-8577, NCI
No
Seth P. Lerner, MD, Baylor College of Medicine
Baylor College of Medicine
M.D. Anderson Cancer Center
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
Baylor College of Medicine
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP