LOBSTER
An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
Sponsor study identifier
observational
450
2 countries
7
Study Start
June 8, 2022
Actual (reported)Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2021
Actual (reported)October 18, 2021
Actual (reported)June 8, 2022
Actual (reported)October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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
Urine and tissue specimens
Tony Lough
Pacific Edge Pty Ltd
First Submitted
October 5, 2021
First Posted
October 18, 2021
Study Start
June 8, 2022
Actual (reported)Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Clayton, Victoria, 3165, Australia
Study Completion
January 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 17, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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