Non-muscle Invasive Bladder Cancer (NMIBC)NCT07187063
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
A study testing UroAmp Test (Convergent Genomics, Inc.) in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Lahey Clinic at 1 site in United States.
Trial summary
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- UroAmp Test (Convergent Genomics, Inc.)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Jan 2029
- Phase
- Interventional
- 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
Who may be able to join
- AUA high-risk bladder cancer1
- Received induction BCG or gemcitabine/docetaxel
- Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)
Who cannot join
- High-risk NMIBC within 3 years
- Prior induction intravesical therapy
- Variant histology
- Concurrent upper tract disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colette Osborne contact
United States1 site, 1 recruiting
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Linda Topjian, 7817448711, linda.m.topjian@lahey.org
About this study
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
- Being tested
- UroAmp Test (Convergent Genomics, Inc.)
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroAmp Test (Convergent Genomics, Inc.)Diagnostic test
Non-invasive genomic urine test that can reliably detect, monitor, and predict the risk of urothelial cancer or its recurrence, potentially before signs and symptoms develop or become detectable by historical standards of care.
| Study group | Role | What they receive |
|---|---|---|
| De-Intensified Arm | Experimental | Less-frequent cystoscopy surveillance Receives: Diagnostic Test: UroAmp Test (Convergent Genomics, Inc.) |
| Standard Surveillance Arm | No intervention | Regular follow-ups and standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cystoscopies
The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.
Measured: From enrollment to 24 months
Secondary outcomes (3)
Event-free survival
An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease
Measured: From enrollment to 24 months
Recurrence-free survival
We will compare the rate of any recurrences (including low-grade) between the De-intensified and the standard surveillance groups
Measured: From enrollment to 24 months
Patient-reported outcomes
The National Comprehensive Cancer Network Distress thermometer and the European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Non-Muscle Invasive Bladder Cancer (NMIBC-24) Module will be collected and compared between study arms
Measured: From enrollment to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew B Clements, MD, MS, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187063
- Sponsor's protocol ID
- 20233622
- Status last verified
- Nov 2026
- First submitted
- 15 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Considering whether to involve other sites in the trial
Publications
Clinical Trials in Progress: Bladder Cancer: Monday, April 28, 9-11 am. Journal of Urology. https://doi.org/10.1097/01.JU.0001110440.53375.7d
Salari K, Sundi D, Lee JJ, Wu S, Wu CL, DiFiore G, Yan QR, Pienkny A, Lee CK, Oberlin D, Barme G, Piser J, Kahn R, Collins E, Phillips KG, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, Evans-Holm ME, MacBride AR, Fischer DS, Haddadzadeh IJ, Mazzarella BC, Gray JW, Koppie TM, Bicocca VT, Levin TG, Lotan Y, Feldman AS. Development and Multicenter Case-Control Validation of Urinary Comprehensive Genomic Profiling for Urothelial Carcinoma Diagnosis, Surveillance, and Risk-Prediction. Clin Cancer Res. 2023 Sep 15;29(18):3668-3680. doi: 10.1158/1078-0432.CCR-23-0570.
PubMed 37439796Bicocca VT, Phillips KG, Fischer DS, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, MacBride AR, Jensen BW, Mazzarella BC, Koppie T, Korkola JE, Gray JW, Levin TG. Urinary Comprehensive Genomic Profiling Correlates Urothelial Carcinoma Mutations with Clinical Risk and Efficacy of Intervention. J Clin Med. 2022 Sep 30;11(19):5827. doi: 10.3390/jcm11195827.
PubMed 36233691
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07187063
- Acronym / sponsor ID
- 20233622
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 22 Sep 2025 (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.
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-Intensified Arm | Experimental | Diagnostic Test: UroAmp Test (Convergent Genomics, Inc.)Less-frequent cystoscopy surveillance |
| Standard Surveillance Arm | No intervention | –Regular follow-ups and standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AUA high-risk bladder cancer1
- Received induction BCG or gemcitabine/docetaxel
- Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)
Key exclusion criteria (4 listed)
- High-risk NMIBC within 3 years
- Prior induction intravesical therapy
- Variant histology
- Concurrent upper tract disease
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 |
|---|---|---|
| UroAmp Test (Convergent Genomics, Inc.)Non-invasive genomic urine test that can reliably detect, monitor, and predict the risk of urothelial cancer or its recurrence, potentially before signs and symptoms develop or become detectable by historical standards of care. | Diagnostic test | De-Intensified Arm |
Primary outcome
Number of cystoscopies
Time frame: From enrollment to 24 months
The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.
3 secondary outcomes
Event-free survival
Time frame: From enrollment to 24 months
Recurrence-free survival
Time frame: From enrollment to 24 months
Patient-reported outcomes
Time frame: From enrollment to 24 months
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 3 Nov 2026.
- BackgroundClinical Trials in Progress: Bladder Cancer: Monday, April 28, 9-11 am. Journal of Urology. https://doi.org/10.1097/01.JU.0001110440.53375.7d
- Background: PubMed 37439796Salari K, Sundi D, Lee JJ, Wu S, Wu CL, DiFiore G, Yan QR, Pienkny A, Lee CK, Oberlin D, Barme G, Piser J, Kahn R, Collins E, Phillips KG, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, Evans-Holm ME, MacBride AR, Fischer DS, Haddadzadeh IJ, Mazzarella BC, Gray JW, Koppie TM, Bicocca VT, Levin TG, Lotan Y, Feldman AS. Development and Multicenter Case-Control Validation of Urinary Comprehensive Genomic Profiling for Urothelial Carcinoma Diagnosis, Surveillance, and Risk-Prediction. Clin Cancer Res. 2023 Sep 15;29(18):3668-3680. doi: 10.1158/1078-0432.CCR-23-0570.
- Background: PubMed 36233691Bicocca VT, Phillips KG, Fischer DS, Caruso VM, Goudarzi M, Garcia-Ransom M, Lentz PS, MacBride AR, Jensen BW, Mazzarella BC, Koppie T, Korkola JE, Gray JW, Levin TG. Urinary Comprehensive Genomic Profiling Correlates Urothelial Carcinoma Mutations with Clinical Risk and Efficacy of Intervention. J Clin Med. 2022 Sep 30;11(19):5827. doi: 10.3390/jcm11195827.
- Patient-oriented presentation on the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Considering whether to involve other sites in the trial
Related trials for Non-muscle Invasive Bladder Cancer (NMIBC)
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
Active, not recruitingPhase 3
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
Non-Muscle Invasive Bladder Neoplasms
RecruitingPhase 2
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
Non-Muscle-Invasive Bladder Cancer (NMIBC)
RecruitingPhase 3
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Non-Muscle Invasive Bladder Neoplasms
RecruitingObservational study
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
Non-Muscle Invasive Bladder Neoplasms
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.
Colette Osborne contact
Matthew B Clements, MD, MS principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroAmp Test (Convergent Genomics, Inc.) in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by Lahey Clinic at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Linda Topjian (7817448420, Linda.M.Topjian@lahey.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cystoscopies (time frame: From enrollment to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07187063, which also lists 3 linked publications.
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 3 Nov 2026.