Upper Tract Urothelial CarcinomaNCT07793240
Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)
An observational study of Upper Tract Urothelial Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The study will evaluate the feasibility of collecting ctDNA data for UTUC patients in perioperative setting and if the data generated can help with design of future prospective trials for perioperative therapy in UTUC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- Signatera testing
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2029
- 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: HG UTUC patients planned for systemic therapy and or surgical intervention that will have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting).
Who may be able to join
- HG UTUC patients planned for systemic therapy and or surgical intervention that will have ctDNA Signatera testing.
Who cannot join
- UTUC patients without high grade disease that is not planned for either systemic therapy or surgical intervention and not planned to have ctDNA Signatera testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Sin Chan, MS, 410-614-3630, schan44@jhmi.edu
Jeannie Hoffman-Censtis, MD
About this study
Official title: Exploring the Use of Tumor Informed Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)
The study will evaluate the feasibility of collecting ctDNA data for UTUC patients in perioperative setting and if the data generated can help with design of future prospective trials for perioperative therapy in UTUC.
Read the detailed description
This study will provide contemporary data for patients with UTUC in the perioperative setting that is unanticipated to become available through large interventional trials. Preliminary data from this study could inform future prospective trials aimed at intensifying or de-intensifying perioperative therapy in UTUC. The study will assess 1) the feasibility of obtaining tumor informed ctDNA on the Signatera platform in patients with High Grade Upper Tract Urothelial Cancer (HG UTUC) planned for systemic therapy and or surgical intervention, 2) if perioperative ctDNA dynamics in UTUC correlate with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery, and 3) if perioperative ctDNA dynamics in UTUC are prognostic for survival estimates as they are in muscle invasive bladder cancer (MIBC). Preliminary data from this study may also support clinical decisions of renal retention in patients treated with chemotherapy who chose to defer surgery.
- Conditions
- Upper Tract Urothelial Carcinoma
- Being tested
- Signatera testing
- Keywords
- ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signatera testingDiagnostic test
Standard Signatera testing for ctDNA at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| High Grade (HG) Upper Tract Urothelial Cancer (UTUC) | Patients HG UTUC planned for systemic therapy and or surgical intervention will be recruited and have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting) at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy. Receives: Diagnostic Test: Signatera testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of of tumor informed ctDNA test results on Signatera platform available
Percent of ctDNA results available at the protocol specified timepoints.
Measured: until end of surveillance or adjuvant therapy, approximately 5 years
Correlation between perioperative ctDNA dynamics in UTUC with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery
Measured at or close to baseline, q4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy, approximately 5 years
Measured: Up to approximately 5 years
Number of patients with ctDNA decline to zero and radiographic complete response after treatment
Number of patients with ctDNA decline to zero post-treatment with complete response per RECIST 1.1.
Measured: until end of surveillance or adjuvant therapy, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeannie Hoffman-Censits, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793240
- Sponsor's protocol ID
- IRB00569996
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Tumor Informed Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)
- ClinicalTrials.gov ID
- NCT07793240
- Acronym / sponsor ID
- IRB00569996
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- ctDNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 28 Aug 2026 (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 study will evaluate the feasibility of collecting ctDNA data for UTUC patients in perioperative setting and if the data generated can help with design of future prospective trials for perioperative therapy in UTUC.
Detailed description
This study will provide contemporary data for patients with UTUC in the perioperative setting that is unanticipated to become available through large interventional trials. Preliminary data from this study could inform future prospective trials aimed at intensifying or de-intensifying perioperative therapy in UTUC. The study will assess 1) the feasibility of obtaining tumor informed ctDNA on the Signatera platform in patients with High Grade Upper Tract Urothelial Cancer (HG UTUC) planned for systemic therapy and or surgical intervention, 2) if perioperative ctDNA dynamics in UTUC correlate with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery, and 3) if perioperative ctDNA dynamics in UTUC are prognostic for survival estimates as they are in muscle invasive bladder cancer (MIBC). Preliminary data from this study may also support clinical decisions of renal retention in patients treated with chemotherapy who chose to defer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Grade (HG) Upper Tract Urothelial Cancer (UTUC) | – | Diagnostic Test: Signatera testingPatients HG UTUC planned for systemic therapy and or surgical intervention will be recruited and have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting) at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HG UTUC patients planned for systemic therapy and or surgical intervention that will have sequential ctDNA ordered as per standard Signatera testing (approved for patients with high risk urothelial cancer undergoing immunotherapy or in perioperative setting).
Key inclusion criteria (1 listed)
- HG UTUC patients planned for systemic therapy and or surgical intervention that will have ctDNA Signatera testing.
Key exclusion criteria (1 listed)
- UTUC patients without high grade disease that is not planned for either systemic therapy or surgical intervention and not planned to have ctDNA Signatera testing.
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 |
|---|---|---|
| Signatera testingStandard Signatera testing for ctDNA at or close to baseline, every 4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy. | Diagnostic test | High Grade (HG) Upper Tract Urothelial Cancer (UTUC) |
Primary outcome
Percent of of tumor informed ctDNA test results on Signatera platform available
Time frame: until end of surveillance or adjuvant therapy, approximately 5 years
Percent of ctDNA results available at the protocol specified timepoints.
Correlation between perioperative ctDNA dynamics in UTUC with pathologic and clinical outcomes in patients with UTUC who proceed to surgery or renal preservation following induction therapy and or surgery
Time frame: Up to approximately 5 years
Measured at or close to baseline, q4-6 weeks on treatment, before and after surgical intervention, on surveillance and or adjuvant therapy, approximately 5 years
Number of patients with ctDNA decline to zero and radiographic complete response after treatment
Time frame: until end of surveillance or adjuvant therapy, approximately 5 years
Number of patients with ctDNA decline to zero post-treatment with complete response per RECIST 1.1.
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 29 Oct 2026.
Related trials for Upper Tract Urothelial Carcinoma
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
RecruitingPhase 2
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Low Grade Upper Tract Urothelial Carcinoma
Not yet recruitingPhase 2
Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk UTUC ( LUXUS07.1 )
Urothelial Carcinoma of the Renal Pelvis and Ureter, Neoadjuvant Therapy
Recruiting
Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma
Upper Tract Urothelial Carcinoma
RecruitingObservational study
Urinary Cell-Free DNA Liquid Biopsy for Urothelial Cancer Diagnosis and Origin Identification
Urothelial Carcinoma (UC), Upper Tract Urothelial Carcinoma
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.
Jeannie Hoffman-Censits, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Tract Urothelial Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 1 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: opening soon, as of the sponsor's last update on 29 Oct 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 Sin Chan, MS (410-614-3630, schan44@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of of tumor informed ctDNA test results on Signatera platform available (time frame: until end of surveillance or adjuvant therapy, approximately 5 years). 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 29 Oct 2026.