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| Sponsored by: |
Lawson Health Research Institute |
|---|---|
| Information provided by: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00318266 |
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: | Cohort, Prospective |
| Official Title: | NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | January 2009 |
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 |
Patient with a history og pTis, pT1, larger ( >2 cm) pTa or multiple pTa bladder tumors.
Inclusion Criteria:
Written Informed Consent prior to any study-related procedures.
Exclusion Criteria:
Contacts and Locations| Contact: Angela Gough | 519-685-8300 ext 52652 | angela.gough@lhsc.on.ca |
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4G5 | |
| Principal Investigator: Jonathan Izawa, MD, FRCSC | |
| Principal Investigator: | Jonathan Izawa, MD FRCSC | University of Western Ontario, Canada |
More Information
| Responsible Party: | Lawson Health Research Institute ( Dr. Jonathan Izawa ) |
| Study ID Numbers: | R-05-885, 11720E |
| Study First Received: | April 24, 2006 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00318266 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Detection of Bladder Cancer using NMP22 Urine Test Kit |
|
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms |
|
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |
