Urothelial Bladder CancerLOBSTERNCT05080998
Longitudinal Bladder Cancer Study for Tumour Recurrence
An observational study of Urothelial Bladder Cancer, run by Pacific Edge Limited at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Bladder Cancer
- What is being tested?
- CxBladder Monitor/Monitor+
- How many people
- 450 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 8 Jun 2022to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401
UT Southwestern Medical Center
Dallas, Texas, 75390
Miami VA Healthcare System
Miami, Florida, 33125
University of Washington School of Medicine
Seattle, Washington, 98195
James A. Haley Veteran's Hospital
Tampa, Florida, 33612
White River Junction Veterans Affair Medical Center
White River Junction, Vermont, 05009
About this study
Official title: An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
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.
Read the detailed description
This is a multi-site study recruiting subjects from Veterans Affairs and other medical centers. Subjects will be prospectively recruited to an observational study to validate the performance characteristics of CxBladder Monitor test (Monitor) and the second-generation test, CxBladder Monitor Plus (Monitor+). The study will recruit low, intermediate, and high-risk surveillance subjects, defined as per American Urological Association (AUA) / Society of Urologic Oncology (SUO) guidelines 2016 amendment 2020, previously diagnosed with urothelial carcinoma (UC). Eligible subjects will include those under surveillance for recurrence of UC. A voided urine sample will be collected from each enrolled subject at each of 4 successive surveillance visits. The collected urine will be used for CxBladder testing and central urine cytology. The study will collect primary tumour tissue from the first confirmed tumour, i.e., the primary diagnosis of UC (if available) and any subsequent collections within 12 weeks. Tissue samples from any UC recurrences while in study will also be collected to genotype each tumour using RNA or DNA markers indicative of an elevated risk of UC. Monitor/Monitor+ results will not be reported to patients or physicians. This study primarily aims to clinically validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value, and test-negative rate) of the Cxbladder Monitor/Monitor+ test compared to the reference standard i.e., tumours observed by cystoscopy and confirmed by pathology over a maximum of 4 surveillance visits. Sites are required to be competent in recruiting and completing required test request forms, Case Report Forms (CRF) and sample collection in a professional manner in accordance with good clinical practice (GCP).
- Conditions
- Urothelial Bladder Cancer
- Being tested
- CxBladder Monitor/Monitor+
- Keywords
- Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CxBladder Monitor/Monitor+Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CxBladder Monitor/Monitor+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start8 Jun 2022
- Primary completionOct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Edge Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Lough, Study chair, Pacific Edge Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080998
- Sponsor's protocol ID
- CXBM/2021/VA
- Acronym
- LOBSTER
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients
- ClinicalTrials.gov ID
- NCT05080998
- Acronym / sponsor ID
- LOBSTER / CXBM/2021/VA
- Conditions
- Urothelial Bladder Cancer
- Keywords
- Recurrence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Pacific Edge LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-site study recruiting subjects from Veterans Affairs and other medical centers. Subjects will be prospectively recruited to an observational study to validate the performance characteristics of CxBladder Monitor test (Monitor) and the second-generation test, CxBladder Monitor Plus (Monitor+). The study will recruit low, intermediate, and high-risk surveillance subjects, defined as per American Urological Association (AUA) / Society of Urologic Oncology (SUO) guidelines 2016 amendment 2020, previously diagnosed with urothelial carcinoma (UC). Eligible subjects will include those under surveillance for recurrence of UC. A voided urine sample will be collected from each enrolled subject at each of 4 successive surveillance visits. The collected urine will be used for CxBladder testing and central urine cytology. The study will collect primary tumour tissue from the first confirmed tumour, i.e., the primary diagnosis of UC (if available) and any subsequent collections within 12 weeks. Tissue samples from any UC recurrences while in study will also be collected to genotype each tumour using RNA or DNA markers indicative of an elevated risk of UC. Monitor/Monitor+ results will not be reported to patients or physicians. This study primarily aims to clinically validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value, and test-negative rate) of the Cxbladder Monitor/Monitor+ test compared to the reference standard i.e., tumours observed by cystoscopy and confirmed by pathology over a maximum of 4 surveillance visits. Sites are required to be competent in recruiting and completing required test request forms, Case Report Forms (CRF) and sample collection in a professional manner in accordance with good clinical practice (GCP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm - Patients undergoing surveillance for UC recurrence | – | Diagnostic Test: CxBladder Monitor/Monitor+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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CxBladder Monitor/Monitor+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. | Diagnostic test | Single arm - Patients undergoing surveillance for UC recurrence |
Primary outcome
To clinically validate the performance characteristics of CxBladder Monitor/Monitor+
Time frame: 12 Months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Lough study chair
Pacific Edge Pty Ltd
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Bladder Cancer, run by Pacific Edge Limited at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To clinically validate the performance characteristics of CxBladder Monitor/Monitor+ (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.