NCT00318266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 25, 2017

Status Verified

November 1, 2008

Enrollment Period

2.3 years

First QC Date

April 24, 2006

Last Update Submit

August 24, 2017

Conditions

Bladder Cancer

Keywords

Detection of Bladder Cancer using NMP22 Urine Test Kit

Study Arms (1)

patients with suerficial transitional cell carcinoma

Device: Nuclear Matrix Protein 22 Urine sample kit

Interventions

Nuclear Matrix Protein 22 Urine sample kitDEVICE

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

patients with suerficial transitional cell carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with a history og pTis, pT1, larger ( \>2 cm) pTa or multiple pTa bladder tumors.

You may qualify if:

  • · History of pTis, pT1, large (\>2cm) pTa or multiple pTa bladder cancer tumours.
  • Written Informed Consent prior to any study-related procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jonathan Izawa, MD FRCSC

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 25, 2017

Record last verified: 2008-11

Locations

CA(1)