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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05080998




Registration number
NCT05080998
Ethics application status
Date submitted
5/10/2021
Date registered
18/10/2021
Date last updated
28/02/2025

Titles & IDs
Public title
CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients
Scientific title
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Intermediate and High-Risk Patients
Secondary ID [1] 0 0
CXBM/2021/VA
Universal Trial Number (UTN)
Trial acronym
LOBSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - CxBladder Monitor

Single arm - Patients undergoing surveillance for UC recurrence - Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Only intermediate and high-risk group, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.


Diagnosis / Prognosis: CxBladder Monitor
CxBladder Monitor (CxbM) is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the proposed pathway failure rate versus the standard of care failure rate.
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
1. High and intermediate risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma
2. Subjects must agree to 4 successive visits including urine sample collection at each of the study visits and records review follow-up
3. Able to provide a voided urine sample (a sample from catheterization is not eligible) of the required minimum volume
4. Able to give written consent
5. Able and willing to comply with study requirements
6. Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterization, urethral dilation) in the 14 days before urine collection
2. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
3. Previous muscle invasive bladder tumour (pT2 or greater)
4. Pregnancy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Moorabbin Hospital - Clayton
Recruitment postcode(s) [1] 0 0
3165 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Vermont
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pacific Edge Limited
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Tony Lough
Address 0 0
Pacific Edge Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Donna Smith, MSc (Hons)
Address 0 0
Country 0 0
Phone 0 0
+64 21 243 6696
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05080998