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Screening for Bladder Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was:  Recruiting
M.D. Anderson Cancer Center
University of Rochester
Laval University
Information provided by:
Baylor College of Medicine Identifier:
First received: February 19, 2009
Last updated: December 9, 2010
Last verified: December 2010
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. ]

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
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.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes 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.

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 identifier: NCT00848627

Contact: Susan L. Kinsgton, LVN, CCRP 713-798-8514

United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States
Contact: EDWARD MESSING, MD    585-275-3345   
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Colin Dinney, MD    713-792-3250   
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   
Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
University of Rochester
Laval University
Principal Investigator: Seth P. Lerner, MD Baylor College of Medicine
  More Information

Responsible Party: Seth P. Lerner, Baylor College of Medicine Identifier: NCT00848627     History of Changes
Obsolete Identifiers: NCT00831558
Other Study ID Numbers: H-20395
5 P50 CA091846 07 (PP-S2)
Study First Received: February 19, 2009
Last Updated: December 9, 2010

Keywords provided by Baylor College of Medicine:
Bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on September 21, 2017