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Genetic Susceptibility to Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00848289
Recruitment Status : Recruiting
First Posted : February 20, 2009
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Bladder Cancer 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
Estimated Enrollment : 4500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach
Actual Study Start Date : February 10, 1998
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples Without DNA
blood (about 40 cc or 8 teaspoons), urine


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848289


Contacts
Contact: Xifeng Wu, MD 713-792-3020 xwu@mdanderson.org
Contact: Tao T Le, Program Director, Epidemiology tle@mdanderson.org

Locations
United States, Texas
Baylor College of Medicine Terminated
Houston, Texas, United States, 77030
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Xifeng Wu, MD    713-792-3020    xwu@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Xifeng Wu, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00848289     History of Changes
Other Study ID Numbers: 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 )
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Bladder cancer
Genetic susceptibility
Increased Risk

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Disease Susceptibility
Genetic Predisposition to Disease
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes