Screening for Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Baylor College of Medicine
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
University of Rochester
Laval University
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00848627
First received: February 19, 2009
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue for 2 years after completion of the study.


Condition Intervention
Bladder Cancer
Other: Specimen and questionnaires only

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Since the marker tests will only be administered to individuals with a positive Hemastix test, these are eight possible outcomes (one case with all negative marker tests and seven cases with as least one positive marker tests). [ Time Frame: After last subject completes the study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: March 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Males
60 years of age or older Smokers or history of smoking
Other: Specimen and questionnaires only
Specimen and questionnaires only

Detailed Description:

Reduction of cancer mortality is a stated goal of the National Cancer Institute. Cancer of the bladder is the 4th most commonly diagnosed cancer and 7th leading cause of cancer death in the American men, and represents an important target for mortality-reducing efforts. Furthermore, these tumors, even in early (i.e. curable) stages, usually cause several easily detectable abnormalities, including hematuria, and the presence of abnormal tumor products that are shed into urine or lie within exfoliated malignant cells.

The overall goal of the proposed study is to gain information concerning the performance characteristics of three bladder cancer markers when combined with hematuria testing in detecting bladder cancer.

A mail back questionnaire, completed at the beginning of the study, will provide information about the participants and the results of testings will be reported after each testing period. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue or 2 years after completion of the study. At the time of the evaluation, three bladder cancer marker tests, NMP22 Bladder Chek, ImmunoCyt and UroVysion FISH will be performed, but regardless of the results, a hematuria evaluation will be completed. Data will be updated continually.

The 10 day testing with Hemastix will be repeated 9 months after the first one is completed regardless of the outcome of the first testing.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

MD Anderson Cancer Center, Baylor College of Medicine, University of Rochester Medical Center and Laval University that contain within them county hospitals, Veterans Administrations Hospitals, fee-for-service clinics, and tertiary care facilities will enroll subjects. Each site will devise their own means of soliciting participants in the study.

Criteria

Inclusion Criteria:

  • Men age 60 and over, - who are current cigarette smokers OR - who have a history of at least 20 pack years smoking OR - who have over a 30 pack/year history who have stopped smoking within 10 years of the registration date OR - who have a 40 pack year history of smoking regardless of the quit date, will be eligible for participation.
  • Patients with prostate or renal cancer must have been treated more than 5 years previously and be considered disease-free at the time of entry. In the case of prostate cancer, patients may have only received prostatectomy as their treatment and must have undetectable PSA's at study entry.
  • In the case of calculus disease, patients must be believed to be stone free at time of study entry and could not have had a stone attack within the previous 2 years.
  • Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox, aspirin, etc. will be able to take part in the study and, will be thoroughly worked-up if the only explainable cause of hematuria is receiving anticoagulation medication.

Exclusion Criteria:

  • history of urothelial cancer
  • any malignancy other than non-melanoma skin cancers treated within the past 5 years
  • benign tumors of the urinary tract that are still existent
  • known urinary calculi
  • medical or oncological conditions known to produce hematuria (e.g. glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic radiation therapy)
  • visual, psychological, neurological, musculoskeletal, etc. impairments that would make home testing impractical
  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: NCT00848627

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

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States
Contact: EDWARD MESSING, MD    585-275-3345    edward_messing@urmc.rochester.edu   
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Colin Dinney, MD    713-792-3250    cdinney@mdanderson.org   
Principal Investigator: Colin Dinney, MD         
Principal Investigator: H. Barton Grossman, MD         
Canada, Quebec
Laval University Recruiting
Quebec City, Quebec, Canada
Contact: YVES FRADET, MD    418-691-55    yves.fradet@crhdq.ulaval.ca   
Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
University of Rochester
Laval University
Investigators
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Seth P. Lerner, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00848627     History of Changes
Other Study ID Numbers: H-20395, 5 P50 CA091846 07 (PP-S2)
Study First Received: February 19, 2009
Last Updated: December 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Bladder cancer
Smokers
Hematuria

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014