Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000043831
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
10/01/2012
Date last updated
10/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot observational study of the uRNA-2 urine test for the detection of urinary tract transitional cell carcinoma (TCC) in patients under a schedule of investigative cystoscopies for monitoring of recurrent TCC.
Scientific title
A pilot study to determine the performance characteristics of a novel urine based bladder cancer test (uRNA-2) which detects RNA markers in urine, on patients undergoing monitoring for recurrence of bladder cancer
Secondary ID [1] 279695 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 285525 0
Condition category
Condition code
Cancer 285708 285708 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective study focussing on patients that are undergoing routine investigative cystoscopies for monitoring of recurrent urinary tract TCC. A routine urine sample taken for local cytology and / or urinalysis at the clinic immediately prior to an investigative cystoscopy for the monitoring of recurrent bladder cancer. An aliquot of this sample is taken for the purposes of this study. Sample is aliquotted and preserved in stabilisation liquids and sent to lab for analysis. Aliquots will be used for urine cytology, NMP22 ELISA, NMP22 BladderChek and uRNA-2. Patient medical information is obtained. No deviation from standard care is undertaken. Patients may be asked for additional samples if they present for further scheduled cystoscopies within the duration of the study. No additional visits to clinic will be required as a result of participation in the study. Study participation will be at a maximum of 6 months. Study completion will be after the recruitment of 100 patients at a minimum, data collection cleaning and analysis. It is anticipated that the data output will occur before September 2012.
Intervention code [1] 283972 0
Not applicable
Comparator / control treatment
The single sample of urine is aliquotted into multiple tubes appropriate to the downstream test. Firstly a dipstick test is used to measure specific gravity, presence of white and red blood cells, and infection. 10 mls of urine is added to a NMP22 ELISA stabilization liquid. NMP22 ELISA is an FDA approved IVD which detects the tumour marker Nuclear Matrix Protein 22, present at high levels in the urine of tumor patients. NMP22 BladderChek detects the same marker but is a point of care test requiring 4 drops of urine. This test is performed at the clinical site but results are not used in clinical work up. Urine Cytology is performed as per established protocols; Briefly, ethanol fixed samples are centrifuged to trap cells present in the sample on a membrane. The membrane is transferred to a glass slide and cells are stained prior to examination under a microscope.
Control group
Active

Outcomes
Primary outcome [1] 286243 0
To determine the performance characteristics (sensitivity, specificity, area under the ROC curve, positive and negative predictive values) of the uRNA-2 test for the detection of recurrent TCC in patients with a recent history of urinary tract TCC who have been treated according to standard practice and are undergoing routine investigative cystoscopy.
The gold standard of comparison for recurrence detection is cystoscopy.
Timepoint [1] 286243 0
Output of the study will be at the completion of patient recruitment and data cleaning and analysis. 100 patients are required for this study. Recruitment rates are variable but the recruitment window is estimated to terminate in March 2012.
Secondary outcome [1] 295431 0
To compare the characteristics (sensitivity, specificity, positive and negative predictive values) of the uRNA-2 test for the detection of TCC recurrence to those of NMP22 BladderChek
Timepoint [1] 295431 0
Output of the study will be at the completion of patient recruitment and data cleaning and analysis. 100 patients are required for this study. Recruitment rates are variable but the recruitment window is estimated to terminate in March 2012.
Secondary outcome [2] 295443 0
To compare the characteristics (sensitivity, specificity, area under the ROC curve, positive and negative predictive values) of the uRNA-2 test for the detection of TCC recurrence to those of NMP22 ELISA assay
Timepoint [2] 295443 0
Output of the study will be at the completion of patient recruitment and data cleaning and analysis. 100 patients are required for this study. Recruitment rates are variable but the recruitment window is estimated to terminate in March 2012.

Eligibility
Key inclusion criteria
1. Positive diagnosis for urinary tract TCC over the past 5 years by;
cystoscopy and confirmation by histopathological examination of resected tissue
or
confirmation by histopathological examination of biopsy tissue
2. Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract TCC at intervals prescribed by clinical practitioner
3. Able to provide a voided urine sample of the required minimum volume
4. Able to give written informed consent
5. Able and willing to comply with study requirements
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior genitourinary manipulation in the 14 days before urine collection,
2. Current symptoms specific to urinary tract infection as evident on preliminary examination
3. Current or known history of urinary tract inflammatory disorder,
4. Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders,
5. Recent history of pyelonephritis
6. Total cystectomy of the bladder

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4044 0
New Zealand
State/province [1] 4044 0
Christchurch
Country [2] 4045 0
New Zealand
State/province [2] 4045 0
Bay of Plenty
Country [3] 4046 0
New Zealand
State/province [3] 4046 0
Auckland

Funding & Sponsors
Funding source category [1] 284476 0
Commercial sector/Industry
Name [1] 284476 0
Pacific Edge Ltd
Country [1] 284476 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Pacific Edge Ltd
Address
87 St David St.
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 283402 0
None
Name [1] 283402 0
Address [1] 283402 0
Country [1] 283402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286453 0
New Zealand Multi Regions Ethics Committee
Ethics committee address [1] 286453 0
Ministry Of Health
No.1 THe Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 286453 0
New Zealand
Date submitted for ethics approval [1] 286453 0
07/04/2011
Approval date [1] 286453 0
Ethics approval number [1] 286453 0
MEC/11/EXP012

Summary
Brief summary
This study aims to evaluate the performance of the uRNA-2 test and to compare uRNA-2 with urine cytology and the NMP22 ELISA kit in the investigation of patients with a history of urinary tract TCC who are undergoing monitoring for recurrence of the disease in New Zealand. Urine samples will be taken from patients as part of standard care prior to cystoscopy. An aliquot of this sample will be used for the tests under evaluation in this study. No deviation from patients care will be undertaken as a result of participation in this study. No study results will be communicated to clinicians or patients.
This is a pilot study to determine the utility of this test on a monitoring for recurrence population. Prevalence and performance data from this study will be used to adjust the sample size and comparator evaluation of study ACTRN12612000042842.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33599 0
Address 33599 0
Country 33599 0
Phone 33599 0
Fax 33599 0
Email 33599 0
Contact person for public queries
Name 16846 0
Paul O'Sullivan
Address 16846 0
Pacific Edge Ltd.
87 St David St.
Dunedin 9016
Country 16846 0
New Zealand
Phone 16846 0
+64 3 4795800
Fax 16846 0
Email 16846 0
paul.osullivan@pacificedge.co.nz
Contact person for scientific queries
Name 7774 0
Paul O'Sullivan
Address 7774 0
Pacific Edge Ltd.
87 St David St.
Dunedin 9016
Country 7774 0
New Zealand
Phone 7774 0
+64 3 4795800
Fax 7774 0
Email 7774 0
paul.osullivan@pacificedge.co.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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