NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

NCT ID: NCT00318266

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with suerficial transitional cell carcinoma

Nuclear Matrix Protein 22 Urine sample kit

Intervention Type DEVICE

Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Izawa, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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11720E

Identifier Type: -

Identifier Source: secondary_id

R-05-885

Identifier Type: -

Identifier Source: org_study_id

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