Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000042842
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
An observational study of the uRNA-2 urine test for the monitoring of recurrence of urinary tract transitional cell carcinoma (TCC)
Scientific title
A 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] 262957 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 270678 0
Condition category
Condition code
Cancer 270853 270853 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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. Output of the study will be at the completion of patient recruitment and data cleaning and analysis. 300 patients are required for this study. Recruitment rates are variable but the recruitment window is estimated to terminate in September 2012.
Intervention code [1] 283969 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] 286233 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 history of urinary tract TCC in the last 5 years who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard of recurrence detection to be compared with is cystoscopy.
Timepoint [1] 286233 0
Patients will provide a urine sample at the time of recruitment or prior to their next scheduled cystoscopy. Additional samples may be taken if the patients re-presents during the study window. No additional visit are required as a result of study participation.
Samples are analysed in batches and are not performed in time with clinical work up and are not reported to the clinician.
Secondary outcome [1] 295432 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 [1] 295432 0
Patients will provide a urine sample at the time of recruitment or prior to their next scheduled cystoscopy. Additional samples may be taken if the patients re-presents during the study window. No additional visit are required as a result of study participation.
Samples are analysed in batches and are not performed in time with clinical work up and are not reported to the clinician.

Eligibility
Key inclusion criteria
1. Positive primary or recurrence diagnosis for urinary tract TCC within the past 5 years 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. Patient is able to provide a voided urine sample of the required minimum volume
4. Patient is able to give written informed consent
5. Patient is 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
22/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284462 0
Hospital
Name [1] 284462 0
Royal Melbourne Hospital Urology Dept.
Country [1] 284462 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pacific Edge PTY Ltd.
Address
c/o Pacific Edge Ltd.
87 ST David St.
Dunedin 9016.
Country
New Zealand
Secondary sponsor category [1] 283393 0
None
Name [1] 283393 0
Address [1] 283393 0
Country [1] 283393 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286450 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 286450 0
Mr Paul Anderson
Department of Urology
The Royal Melbourne Hospital
3 Centre
Grattan Street
PARKVILLE VIC 3050
Ethics committee country [1] 286450 0
Australia
Date submitted for ethics approval [1] 286450 0
25/05/2011
Approval date [1] 286450 0
08/08/2011
Ethics approval number [1] 286450 0
2011.084

Summary
Brief summary
This study focuses on patients who were diagnosed positive or had a recurrence for TCC over the past 5 years and who are undergoing a schedule of investigative cystoscopies and treatment for the possible (further) recurrence of urinary tract transitional cell cancer.
Eligible consenting patients will provide a freshly voided mid-stream urine sample prior to cystoscopy (as per normal clinical practice). Part of this sample will be used for local cytology and other analysis as deemed clinically appropriate. The remainder will be used for dipstick analysis of specific gravity, presence of red and white blood cells and infection. Aliquots will be taken for uRNA-2, NMP22 BladerChek, NMP22 ELISA and urine cytology.
This is a non interventional study. No deviation from patient care is undertaken. Results of the study tests are not communicated to the clinician and are therefore have no effect on patient treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33091 0
Address 33091 0
Country 33091 0
Phone 33091 0
Fax 33091 0
Email 33091 0
Contact person for public queries
Name 16338 0
Paul O'Sullivan
Address 16338 0
Pacific Edge Ltd.
87 St David St.
Dunedin 9016
Country 16338 0
New Zealand
Phone 16338 0
+64 3 479 5800
Fax 16338 0
Email 16338 0
[email protected]
Contact person for scientific queries
Name 7266 0
Paul O'Sullivan
Address 7266 0
Pacific Edge Ltd.
87 St David St.
Dunedin 9016
Country 7266 0
New Zealand
Phone 7266 0
+64 3 479 5800
Fax 7266 0
Email 7266 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.