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
  Purpose

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.


Condition Intervention
Bladder Cancer
Healthy
Other: Specimens, personal and follow-up telephone interviews

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: H-8577:Genetic Susceptibility to Bladder Cancer: A Molecular Epidemiology Approach

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

blood (about 40 cc or 8 teaspoons), urine


Estimated Enrollment: 2200
Study Start Date: July 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with bladder cancer.
Other: Specimens, personal and follow-up telephone interviews
Specimens, personal and follow-up telephone interviews
2
Healthy patients
Other: Specimens, personal and follow-up telephone interviews
Specimens, personal and follow-up telephone interviews

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848289

Contacts
Contact: Susan L. Kingston, LVN, CCRP 713-798-8514 slk@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Susan L. Kingston, LVN, CCRP    713-798-8514    slk@bcm.edu   
Principal Investigator: Seth P. Lerner, MD         
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: XIFENG WU, MD    713-792-0807    xwu@mdanderson.org   
Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Seth P. Lerner, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00848289     History of Changes
Other Study ID Numbers: H-8577, NCI
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Bladder cancer
Genetic susceptibility
Increased Risk

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

ClinicalTrials.gov processed this record on October 21, 2014