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NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00318266
Collaborator
(none)
73
Enrollment
1
Location
28
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Jan 1, 2006
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT00318266
    Other Study ID Numbers:
    • R-05-885
    • 11720E
    First Posted:
    Apr 26, 2006
    Last Update Posted:
    Aug 25, 2017
    Last Verified:
    Nov 1, 2008
    Keywords provided by Lawson Health Research Institute
    Detection of Bladder Cancer using NMP22 Urine Test Kit
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Aug 25, 2017