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Trial registered on ANZCTR


Registration number
ACTRN12616001181493
Ethics application status
Approved
Date submitted
21/03/2016
Date registered
29/08/2016
Date last updated
29/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of the efficacy of the Cxbladder a urine test for the detection of urothelial carcinoma in patients presenting with macroscopic or microscopic haematuria.
Scientific title
An observational study of the performance characteristics including Sensitivity and NPV of the Cxbladder urine test for in the detection of urothelial carcinoma in patients presenting with macroscopic or microscopic haematuria


Secondary ID [1] 288314 0
Nil
Universal Trial Number (UTN)
U1111-1178-4425
Trial acronym
CHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder cancer 297284 0
haematuria 299092 0
Condition category
Condition code
Cancer 297475 297475 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an observational study of a molecular diagnostic test, Cxbladder used in the detection of Urothelial Carcinomas (UC) in patients presenting with macroscopic or microscopic haematuria. Cxbladder is a diagnostic urine based test, which quantifies 5 RNA biomarkers present at elevated levels in the urine of patients with UC. A midstream urine sample is collected from the patient as part of standard care. A 5 ml aliquot of this sample is stabilised with Cxbladder proprietary liquid buffer stabilisation solution and sent to a central laboratory for analysis . The remainder of the urine sample may be used for other diagnostic tests as clinically indicated. This is an observational study. The information collected during the study will not be used in any way to influence the clinical evaluation process or decisions made with regard to any patients enrolled in the study.

Samples are analysed and scores determined as below (however no sites are provided with direct patient scores).
Score <0.12 NPV of 97%, High probability of no urothelial carcinoma
0.12 < Score < 0.23 NPV of 94%, Low probability of urothelial carcinoma but suggests further clinical investigation needed
Score > 0.23 PPV of 68%, High probability of urothelial carcinoma

The study is observational only and results are only provided to the site after the study is closed and for the purpose of collating data for publication.
Intervention code [1] 293609 0
Diagnosis / Prognosis
Comparator / control treatment
To determine the performance characteristics (accuracy, sensitivity, specificity, positive and negative predictive values) of the Cxbladder test for the detection of primary UC in patients with a recent history haematuria and who are undergoing investigative cystoscopy. Analysis will be performed on macroscopic and microscopic haematuria cohorts.

Performance characteristics of Cxbladder will be evaluated with and compared to other clinical sites, and to the results of the published clinical study (J Urology 2012). The current gold standard for comparison of UC detection is cystoscopy plus follow up.

The cystoscopy is the reference test in this study and is conducted the same day as the urine diagnostic test.
During the cystoscopy, samples are collected and pathology conducted to confirm the presence of urothelial carcinoma of the bladder.
Control group
Active

Outcomes
Primary outcome [1] 297041 0
The sensitivity and specificity of the Cxbladder test will be compared to cystoscopy results.
Timepoint [1] 297041 0
Approximately 100 patients with macroscopic haematuria and 200 patients with microscopic haematuria will participate in the study. The primary timepoint is for analysis is after all participants have completed Cxbladder urine tests and required clinical results and history for each patient is recorded. The estimate for completion of recruitment of 300 patients but is dependent on patient presentation and clinical resources for recruitment.
Secondary outcome [1] 319905 0
None
Timepoint [1] 319905 0
Nil

Eligibility
Key inclusion criteria
Patient is undergoing investigative cystoscopies for investigation of recent macroscopic or microscopic haematuria

Patient must be able and willing to comply with study requirements.

Patients must be over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior history of urotherial carcinoma.
Prior genitourinary manipulation in the 14 days before urine collection.
Current or known history of urinary tract inflammatory disorder.
Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders.
Recent history of pyelonephritis.
Patient is presenting with symptoms indicative of a current urinary tract infection.
Patient is presenting with symptoms indicative of bladder or renal calculi.
Prior history (past 12 months of an episode of macroscopic haematuria with confirmed diagnosis (malignant or otherwise).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
All enrolled patients that satisfy the protocol requirements will be included in the analysis.
Approximately 100 patients with macroscopic haematuria and 200 patients with microscopic haematuria are required for comparison of the accuracy of Cxbladder and a reference test. Accuracy refers to the difference between specificities plus the difference between sensitivities.

Calculations for performance characteristics and efficacy are given below. Results for macroscopic and microscopic haematuria populations will be calculated separately and as a combined data set.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 5034 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 5035 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 10526 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 10527 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 12520 0
3052 - Parkville
Recruitment postcode(s) [2] 12521 0
4006 - Herston
Recruitment postcode(s) [3] 22242 0
2139 - Concord
Recruitment postcode(s) [4] 22243 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 292686 0
Commercial sector/Industry
Name [1] 292686 0
Pacific Edge Diagnostics
Address [1] 292686 0
69 Ridge Road
Kallista VIC 3791
Country [1] 292686 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pacific Edge Diagnostics Pty Ltd
Address
60 Ridge Road
Kallista VIC 3791
Country
Australia
Secondary sponsor category [1] 291407 0
None
Name [1] 291407 0
n/a
Address [1] 291407 0
n/a
Country [1] 291407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294157 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 294157 0
Level 6
East
300 Grattan Street
Parkville Victoria
Ethics committee country [1] 294157 0
Australia
Date submitted for ethics approval [1] 294157 0
29/08/2014
Approval date [1] 294157 0
01/10/2014
Ethics approval number [1] 294157 0
HREC/14/MH230

Summary
Brief summary
This study aims to investigate the diagnostic test accuracy of Cxbladder for diagnosis of bladder cancer in patients presenting with macroscopic or microscopic haematuria.

Who is it for?
You may be eligible to join this study if you are aged between 18 years or over and are to undergo an investigative cystoscopy for recent macroscopic or microscopic haematuria (presence of red blood cells in the urine) and do not have a prior history of urothelial carcinoma of the bladder.

Study details
All participants of this study will provide urine samples just prior to undergoing cystoscopy. These samples will be analysed using Cxbladder diagnostic test and results compared with pathology results from samples collected during cystoscopy. These findings will not be used in treatment decisions but will help establish if Cxbladder test can be used in diagnosis of bladder cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62734 0
A/Prof Paul Anderson
Address 62734 0
Urology Department, Royal Melbourne Hospital, Cnr Grattan St and Royal Parade, Parkville VIC 3052
Country 62734 0
Australia
Phone 62734 0
+61 3 9342 7294
Fax 62734 0
+61 3 9342 8928
Email 62734 0
mr.paul.anderson@gmail.com
Contact person for public queries
Name 62735 0
Dr Anabela Correia
Address 62735 0
Pacific Edge Pty Ltd Suite 4/501 Toorak Road Toorak VIC 3142
Country 62735 0
Australia
Phone 62735 0
+61 412 003 606
Fax 62735 0
Email 62735 0
anabela.correia@pacificedgedx.com
Contact person for scientific queries
Name 62736 0
Mr Paul O'Sulivan
Address 62736 0
Pacific Edge Ltd
87 St David St
PO Box 56
Dunedin 9016
Country 62736 0
New Zealand
Phone 62736 0
+64 3 479 5800
Fax 62736 0
+64 3 479 5801
Email 62736 0
paul.osullivan@pacificedge.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary