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NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318266
First received: April 24, 2006
Last updated: August 24, 2017
Last verified: November 2008
  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: Nuclear Matrix Protein 22 Urine sample kit

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:


Further study details as provided by Lawson Health Research Institute:

Enrollment: 73
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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   (Adult, Senior)
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.
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
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: NCT00318266

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

Responsible Party: 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: August 24, 2017

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 September 21, 2017