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Genetic Susceptibility to Bladder Cancer

This study is currently recruiting participants.
Verified September 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848289
First Posted: February 20, 2009
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
February 19, 2009
February 20, 2009
September 11, 2017
February 10, 1998
August 2019   (Final data collection date for primary outcome 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 [ Time Frame: After last subject has completed the study, up to 5 years ]
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
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 ]
Complete list of historical versions of study NCT00848289 on ClinicalTrials.gov Archive Site
  • Frequencies of polymorphisms in those genes that regulate the metabolism of carcinogens in tobacco smoke [ Time Frame: 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 [ Time Frame: After the last subject has completed the study, up to 5 years per individual participation ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.
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.
Observational
Observational Model: Other
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
Behavioral: Interviews
Data collected by personal interview for Epidemiology and Nutrition Questionnaires, with personal and follow-up telephone interviews.
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.
Intervention: Behavioral: Interviews
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4500
August 2019
August 2019   (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.
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact: Xifeng Wu, MD 713-792-3020 xwu@mdanderson.org
Contact: Tao T Le, Program Director, Epidemiology tle@mdanderson.org
United States
 
 
NCT00848289
LAB98-040
LAB98-040 ( Other Identifier: MD Anderson Cancer Center )
5P50CA091846-14 ( U.S. NIH Grant/Contract )
H-8577 ( Other Identifier: Baylor College of Medicine )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Xifeng Wu, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2017