Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001180404
Ethics application status
Approved
Date submitted
21/03/2016
Date registered
29/08/2016
Date last updated
7/01/2020
Date data sharing statement initially provided
14/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The utility of the CxBladder in detecting recurrent tumours in patients undergoing intravesical Bacillus Calmette-Guerin (BCG) therapy or Mitomycin C (MMC) therapy for bladder cancer.
Scientific title
An observational study of the performance characteristics including Sensitivity and NPV of the Cxbladder urine test in patients undergoing intravesical therapy (BCG treatment) Mitomycin C (MMC) therapy as treatment for urothelial carcinoma.
Secondary ID [1] 288306 0
Nil
Universal Trial Number (UTN)
U1111-1178-4258
Trial acronym
CBCGT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder cancer 297283 0
transitional cell carcinoma 299093 0
urothelial carcinoma 299094 0
Condition category
Condition code
Cancer 297473 297473 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim is to determine whether Cxbladder, a urine diagnostic test is as accurate as cystoscopy current technologies in determining freedom from, or recurrence of cancer in the a group of patients having undergone BCG immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder.

Hypothesis: The Cxbladder test is accurate at predicting the recurrence status of bladder cancer in patients who have undergone intra-vesical therapy.

Patients are required to provide samples prior to treatment and then at 1,2,3,6 months and one additional timepoint (1-3 years) following BCG or MCC treatment.

Samples are analysed and gene expression scores determined – however no sites are provided with direct patient scores. 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.

Samples are analysed and gene expression scores are determined as (but not provided to site)
1) Normal <0.12
2) Elevated 0.12-0.23
3) High >0.23 (Positive Predictive Value (PPV) of 68%. High probability of urothelial carcinoma)
Intervention code [1] 293608 0
Diagnosis / Prognosis
Comparator / control treatment
The reference standard is for patients to under go a flexible cystoscopy prior to treatment, then at 1,2,3 and 6 months post treatment.

Patients (both those under going BCG/MMC treatment and participants who have undergone DMSO /heparin therapy for painful bladder syndrome who act as a control group) provide urine samples and these are analysed and gene expression determined – however no sites are provided with direct patient scores. 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.

In all cases, the urologist will examine the bladder under cystoscopy and bladder tissue is collected (if appropriate) and analysed to presence of urothelial carcimona (grade and stage).

A ‘positive’ cystoscopy result indicates the presence of urothelial carcinoma.
Control group
Active

Outcomes
Primary outcome [1] 297039 0
The aim is to determine whether Cxbladder is as good as cystoscopy in determining freedom from or recurrence of cancer in the group of patients having undergone BCG immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder.

Specifically, to compare cystoscopy findings (positive or negative for cancer recurrence) with Cxbladder test result (positive or negative for cancer recurrence).

The sensitivity and specificity of the Cxbladder test will be compared to cystoscopy results.
Timepoint [1] 297039 0
At prior to treatment (week 1), the post treatment 1 month (week 5) ,2 months (week 8) then ,3 months and 6 months and an additional point 1-3 years after following BCG treatment or Mitomycin C intravesical chemotherapy
Secondary outcome [1] 324526 0
To compare Cxbladder test result with a group of patients undergoing intravesical therapy for non-cancer diseases (DMSO or intravesical heparin for painful bladder syndromes): control group
Timepoint [1] 324526 0
At prior to treatment (week 1), the post treatment 1 month (week 5) ,2 months (week 8) then ,3 months and 6 months and an additional point 1-3 years following treatment.

Eligibility
Key inclusion criteria
Men and women between 18 and 85 years undergoing BCG or Mitomycin C (MMC) therapy for urothelial carcinoma or DMSO/heparin therapy for painful bladder syndrome at Concord Hospital.

The study invites patients undergoing DMSO/heparin therapy as a control group - The Cxbladder results from these patients are compared against those for the BCG or Mitomycin C (MMC) therapy patients.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients declining involvement in the study and patients with obvious active urinary tract infections.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Interim statistical analysis will be performed at the completion of 10 patients undergoing BCG therapy.

Relative performance of Cxbladder will be determined on a sample by sample basis and per patient overall. Sample size estimates may be revised depending on the outcomes of the interim analysis.

Final analysis of performance of Cxbladder will be performed upon completion of sampling for all proposed patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/11/2014
Date of last participant enrolment
Anticipated
30/06/2017
Actual
31/12/2017
Date of last data collection
Anticipated
30/06/2019
Actual
17/12/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5032 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 12519 0
2137 - Concord

Funding & Sponsors
Funding source category [1] 292684 0
Commercial sector/Industry
Name [1] 292684 0
Pacific Edge Diagnostics Pty Ltd
Country [1] 292684 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] 291405 0
None
Name [1] 291405 0
N/A
Address [1] 291405 0
N/a
Country [1] 291405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294156 0
Sydney Local Health District Human Research Ethics Committee - CRGH
Ethics committee address [1] 294156 0
Ethics committee country [1] 294156 0
Australia
Date submitted for ethics approval [1] 294156 0
13/12/2013
Approval date [1] 294156 0
18/02/2014
Ethics approval number [1] 294156 0
HREC/13/CRGH/292 CH62/6/2013-206

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62706 0
Dr Andrew Mitterdorfer
Address 62706 0
Consulting Urologist
12 Mary Street
Auburn NSW 2144
Country 62706 0
Australia
Phone 62706 0
+61 2 9643 1223
Fax 62706 0
+61 2 9749 2569
Email 62706 0
[email protected]
Contact person for public queries
Name 62707 0
Anabela Correia
Address 62707 0
Pacific Edge Pty Ltd
PO Box 2237
Prahran VIC 3181
Country 62707 0
Australia
Phone 62707 0
+61 412 003 606
Fax 62707 0
Email 62707 0
[email protected]
Contact person for scientific queries
Name 62708 0
Paul O'Sullivan
Address 62708 0
Pacific Edge Ltd
87 St David St
PO Box 56
Dunedin 9016
Country 62708 0
New Zealand
Phone 62708 0
+64 3 479 5800
Fax 62708 0
+64 3 479 5801
Email 62708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient data will remain confidential. A summary of study findings may be published in the future once analysed.


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.