NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

Lawson Health Research Institute

Status: Completed

Conditions: Bladder Cancer

Treatments: Device: Nuclear Matrix Protein 22 Urine sample kit

Study type: Observational

Funder types: Other

Identifiers

NCT00318266

R-05-885

11720E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

73 participants in 1 patient group

patients with suerficial transitional cell carcinoma

Treatment:

Device: Nuclear Matrix Protein 22 Urine sample kit