Upper Tract Urothelial CancerNCT06805630
Urine Methylation Markers in UTUC
A study testing Bladder CARE™ in people with Upper Tract Urothelial Cancer, run by Duke University at 1 site in United States.
Trial summary
This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Tract Urothelial Cancer
- What is being tested?
- Bladder CARE™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 30 Dec 2026
- 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
- >=18 years
- Primary UTUC
Who cannot join
- Patients who do not understand and/or are unwilling to sign a written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma
This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Pangea Laboratory LLC for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.
- Conditions
- Upper Tract Urothelial Cancer
- Being tested
- Bladder CARE™
- Keywords
- UTUC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder CARE™Diagnostic test
Urine methylation biomarker test
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary UTUC (upper tract urothelial carcinoma) | Other | Urine DNA samples will be quantified using Bladder CARE™ at baseline, 3 months, and 6 months. Receives: Diagnostic Test: Bladder CARE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation level of urothelial-specific biomarker TRNA-Cys
Measured: Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker SIM2
Measured: Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker NKX1-1
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start7 May 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Abern, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805630
- Sponsor's protocol ID
- Pro00116347
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06805630
- Acronym / sponsor ID
- Pro00116347
- Conditions
- Upper Tract Urothelial Cancer
- Keywords
- UTUC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Feb 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.
This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Pangea Laboratory LLC for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary UTUC (upper tract urothelial carcinoma) | Other | Diagnostic Test: Bladder CARE™Urine DNA samples will be quantified using Bladder CARE™ at baseline, 3 months, and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >=18 years
- Primary UTUC
Key exclusion criteria (1 listed)
- Patients who do not understand and/or are unwilling to sign a written informed consent
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 |
|---|---|---|
| Bladder CARE™Urine methylation biomarker test | Diagnostic test | Patients with primary UTUC (upper tract urothelial carcinoma) |
Primary outcome
Methylation level of urothelial-specific biomarker TRNA-Cys
Time frame: Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker SIM2
Time frame: Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker NKX1-1
Time frame: Baseline, 3 months, 6 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 5 Aug 2026.
- Individual participant dataSharing planned: No
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A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)
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Active, not recruitingPhase 1/2
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
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Not yet recruitingPhase 2
A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
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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.
Michael Abern, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder CARE™ in people with Upper Tract Urothelial Cancer, run by Duke University 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 2 inclusion and 1 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 5 Aug 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?
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?
Methylation level of urothelial-specific biomarker TRNA-Cys (time frame: Baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. 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 5 Aug 2026.