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NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318266
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment
Bladder Cancer Device: Nuclear Matrix Protein 22 Urine sample kit

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.

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers
Study Start Date : January 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
patients with suerficial transitional cell carcinoma Device: Nuclear Matrix Protein 22 Urine sample kit
Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

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 identifier (NCT number): NCT00318266

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

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Responsible Party: Lawson Health Research Institute Identifier: NCT00318266     History of Changes
Other Study ID Numbers: R-05-885
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: November 2008

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

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