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NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318266
First received: April 24, 2006
Last updated: November 12, 2008
Last verified: November 2008
History of Changes
  Purpose

It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will demonstrate improved sensitivity over that of standard urine cytology for patients with superficial transitional cell carcinoma at high risk of recurrence.


Condition Intervention
Bladder Cancer
 Device: Use of Nuclear Matrix Protein 22 Urine sample kit to determine Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: January 2009
Intervention Details:
    Device: Use of Nuclear Matrix Protein 22 Urine sample kit to determine Bladder Cancer
    Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.
Detailed Description:

Patients who have been previously treated for bladder cancer and are at a high risk for recurrence are being monitored for recurrence every 3 months with urine cytology and cystoscopy as part of standard care.The NMP22 Bladder Cancer ® Test Kit has been designed to provide an alternative to regular urine cytology. A urine sample will be provided and divided with a portion being used to assess the NMP22 test kit and the remaining sample to be sent to the lab for regular urine cytology. Patient charts will be reviewed by a medical student to record age, clinical stage, pathologic stage, time to disease progression/recurrence, site of recurrence and survival data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with a history og pTis, pT1, larger ( >2 cm) pTa or multiple pTa bladder tumors.

Criteria

Inclusion Criteria:

  • · History of pTis, pT1, large (>2cm) pTa or multiple pTa bladder cancer tumours.

Written Informed Consent prior to any study-related procedures.

Exclusion Criteria:

  • History of bladder cancer tumours other than those listed in inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318266

Contacts
Contact: Angela Gough 519-685-8300 ext 52652 angela.gough@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4G5
Principal Investigator: Jonathan Izawa, MD, FRCSC            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Jonathan Izawa, MD FRCSC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. Jonathan Izawa, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00318266     History of Changes
Other Study ID Numbers: R-05-885, 11720E
Study First Received: April 24, 2006
Last Updated: November 12, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Detection of Bladder Cancer using NMP22 Urine Test Kit

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 May 19, 2013