Longitudinal Bladder Cancer Study for Tumour Recurrence
LOBSTER
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
1 other identifier
observational
450
2 countries
7
Brief Summary
Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedStudy Start
First participant enrolled
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
November 10, 2025
December 1, 2024
4 years
October 5, 2021
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To clinically validate the performance characteristics of CxBladder Monitor/Monitor+
To clinically validate the performance characteristics - sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and test-negative rate of Monitor and Monitor+ for the detection of recurrent UC in subjects with a recent history of urinary tract UC who are being treated according to standard of care and are concurrently undergoing routine investigative cystoscopy.
12 Months
Study Arms (1)
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. Low-, intermediate-, and high-risk groups, 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.
Interventions
CxBladder Monitor/Monitor+ 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.
Eligibility Criteria
The study will recruit low-, intermediate-, and high-risk surveillance subjects (defined as per AUA/SUP Guidelines 2016, amendment 2020), previously diagnosed with urothelial carcinoma.
You may qualify if:
- Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
- Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
- Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
- Able to give written informed consent
- Able and willing to comply with study requirements
- Aged 18 years or older
You may not qualify if:
- Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
- Previous muscle invasive bladder tumour (pT2 or greater)
- Known pregnancy
- Deferral Criteria
- Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.
- Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.
- If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Miami VA Healthcare System
Miami, Florida, 33125, United States
James A. Haley Veteran's Hospital
Tampa, Florida, 33612, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
White River Junction Veterans Affair Medical Center
White River Junction, Vermont, 05009, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
Monash Health - Moorabbin Hospital
Clayton, Victoria, 3165, Australia
Biospecimen
Urine and tissue specimens
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tony Lough
Pacific Edge Pty Ltd
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
October 18, 2021
Study Start
June 8, 2022
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
November 10, 2025
Record last verified: 2024-12