Urothelial CarcinomauTRACTNCT05874921
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
An observational study of Urothelial Carcinoma and Urothelial Carcinoma Recurrent, run by UroGen Pharma Ltd. at 22 sites in United States.
Trial summary
The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter
- What is being tested?
- Jelmyto (mitomycin) for pyelocalyceal solution
- How many people
- 450 participants
- Where
- 22 sitesUnited States
- Study dates
- 17 Nov 2023to Oct 2030
- How long will I take part?
- 3 Years
- 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: Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.
Who may be able to join
- Adults >18 years old and capable of giving informed consent.
- Diagnosis of UTUC.
- Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).
Who cannot join
- Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).
- Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).
- Pregnancy or lactation.
- Unable to comply with protocol requirements (for prospective data capture).
- Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Khurshid Ghani, MD, kghani@med.umich.edu
- Recruiting
Chesapeake Urology
Baltimore, Maryland, 21204
Rian Dickstein, MD, rdickstein@chesuro.com
- Recruiting
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
Nirmish Singla, MD, 410-955-6100
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
Adam Feldman, MD, afeldman@mgb.org
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Christopher Dall, MD, cdall@mgb.org
- Recruiting
The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Marc Bjurlin, MD, marc_bjurlin@med.unc.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Joshua Meeks, MD, joshua.meeks@northwestern.edu
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Eliza DeFroda, MD, elddmc@health.missouri.edu
- Recruiting
Ohio State University
Columbus, Ohio, 43202
Ahmad Shabsigh, MD, 614-685-4263, Ahmad.Shabsigh@osumc.edu
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Brett Johnson, MD, Brett.Johnson@UTSouthwestern.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
Padraic OMalley, MD, 352-265-8240, Padraic.O'Malley@urology.ufl.edu
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Surena Matin, MD, surmatin@mdanderson.org
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Hristos Kaimakliotis, MD, hkaimakl@iupui.edu
- Recruiting
The State University of Iowa
Iowa City, Iowa, 52242
Michael ODonnell, MD, michael-odonnell@uiowa.edu
- Recruiting
The Feinstein Institutes for Medical Research
Lake Success, New York, 11042
David Hoenig, MD, dhoenig@northwell.edu
- Recruiting
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, 33140
Alan Nieder, MD, Alan.Nieder@msmc.com
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Amy Luckenbaugh, MD, amy.n.luckenbaugh@vumc.org
- Recruiting
Rutgers
New Brunswick, New Jersey, 08903
Saum Ghodoussipour, MD, sg1621@cinj.rutgers.edu
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Katie Murray, MD, Katie.Murray@nyulangone.org
- Recruiting
Providence St. Johns Health Center
Santa Monica, California, 90404
Jennifer Linehan, MD, Jennifer.linehan@providence.org
- Recruiting
SUNY Upstate
Syracuse, New York, 13210
Joseph Jacob, MD, JacobJ@upstate.edu
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, 33612
Wade Sexton, MD, Wade.Sexton@moffitt.org
About this study
Official title: uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.
Read the detailed description
Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death.
Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto.
Example clinical questions:
- How is Jelmyto used in the real world setting?
- What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
- What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
- Did the use of Jelmyto impact clinical decision making and management?
- What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
- What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
- What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto?
- What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD?
- What is the rate and timing of bladder cancer occurrence and/or recurrences?
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent, Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter
- Being tested
- Jelmyto (mitomycin) for pyelocalyceal solution
- Keywords
- Upper Tract Urothelial Cancer, UTUC, UGN-101, Mitomycin C, TCC, Ureteral, Upper Tract, Carcinoma, Kidney, Renal, Gel, Local, Prolonged Release, Slow Release, Kidney Sparing, Recurrence, Neoplasms by Histologic Type, Neoplasms, Urologic Neoplasms, Urogenital Neoplasms
- Medical subject headings
- Carcinoma, Transitional Cell, Carcinoma, Recurrence, Neoplasms by Histologic Type, Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jelmyto (mitomycin) for pyelocalyceal solutionDrug
Also called Jelmyto, UGN-101
The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).
Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations.
| Study group | Role | What they receive |
|---|---|---|
| Jelmyto | Patients with UTUC treated with Jelmyto Receives: Drug: Jelmyto (mitomycin) for pyelocalyceal solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)
To evaluate the tumor ablative effect of JELMYTO in the Registry population
Measured: 3 months
Secondary outcomes (5)
Durability of response at 12, 24, and 36 months in patients who achieve NED after primary treatment with JELMYTO.
To evaluate response to JELMYTO treatment in the Registry population
Measured: 3 years
Recurrence free survival after adjuvant treatment with JEMLYTO
To evaluate response to JELMYTO treatment in the Registry population
Measured: 3 years
Time to recurrence
To evaluate response to JELMYTO treatment in the Registry population
Measured: 3 years
Time to progression
To evaluate response to JELMYTO treatment in the Registry population
Measured: 3 years
Incidence of JELMYTO-related AEs
To assess the safety of JELMYTO in the Registry population
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start17 Nov 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies 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
- Other
- Enrolment
- 450 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- UroGen Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yair Lotan, MD, Principal investigator, UT Southwestern Medical Center at DallasAdam Feldman, MD, Principal investigator, Massachusetts General HospitalSolomon Woldu, MD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874921
- Sponsor's protocol ID
- UT004
- Acronym
- uTRACT
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
- ClinicalTrials.gov ID
- NCT05874921
- Acronym / sponsor ID
- uTRACT / UT004
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent, Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter
- Keywords
- Upper Tract Urothelial Cancer, UTUC, UGN-101, Mitomycin C, TCC, Ureteral, Upper Tract, Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- UroGen Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 25 May 2023 (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 purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.
Detailed description
Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death.
Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto.
Example clinical questions:
- How is Jelmyto used in the real world setting?
- What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
- What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
- Did the use of Jelmyto impact clinical decision making and management?
- What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
- What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
- What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto?
- What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD?
- What is the rate and timing of bladder cancer occurrence and/or recurrences?
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jelmyto | – | Drug: Jelmyto (mitomycin) for pyelocalyceal solutionPatients with UTUC treated with Jelmyto |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.
Key inclusion criteria (3 listed)
- Adults >18 years old and capable of giving informed consent.
- Diagnosis of UTUC.
- Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).
Key exclusion criteria (5 listed)
- Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).
- Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).
- Pregnancy or lactation.
- Unable to comply with protocol requirements (for prospective data capture).
- Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).
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 |
|---|---|---|
| Jelmyto (mitomycin) for pyelocalyceal solutionAlso: Jelmyto, UGN-101The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin). Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations. | Drug | Jelmyto |
Primary outcome
Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)
Time frame: 3 months
To evaluate the tumor ablative effect of JELMYTO in the Registry population
5 secondary outcomes
Durability of response at 12, 24, and 36 months in patients who achieve NED after primary treatment with JELMYTO.
Time frame: 3 years
Recurrence free survival after adjuvant treatment with JEMLYTO
Time frame: 3 years
Time to recurrence
Time frame: 3 years
Time to progression
Time frame: 3 years
Incidence of JELMYTO-related AEs
Time frame: 3 years
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 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.
Yair Lotan, MD principal investigator
UT Southwestern Medical Center at Dallas
Adam Feldman, MD principal investigator
Massachusetts General Hospital
Solomon Woldu, MD principal investigator
UT Southwestern Medical Center at Dallas
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Urothelial Carcinoma Recurrent, run by UroGen Pharma Ltd. at 22 sites 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 5 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 29 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 22 sites 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 Michael Louie, MD, MPH, MSc (855-987-6436, registry@urogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment) (time frame: 3 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 29 Sep 2026.