An observational study in Urothelial Carcinoma, Urothelial Carcinoma Recurrent and Urothelial Carcinoma Ureter, sponsored by UroGen Pharma Ltd.. Recruiting at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by UroGen Pharma Ltd. · Observational
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Among 10 studies in Carcinoma, Transitional Cell by UroGen Pharma Ltd. — 2 open to participants now, 3 under way, 2 of them phase 3. Carcinoma, Transitional Cell · UroGen Pharma Ltd..
Among the 10 studies in Carcinoma, Transitional Cell by UroGen Pharma Ltd., this one is the only one that started in 2023, is the only observational one, and was the 8th registered.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 180 are open to participants now.
Browse Carcinoma, Transitional Cell studies →2 of the 10 studies in Carcinoma, Transitional Cell by UroGen Pharma Ltd. are open now, in 9 countries. Recruiting first, the newest first:
UroGen Pharma Ltd. · Sites in United States, Bulgaria, Georgia and 6 more countries
Ages 18+
By country, each count listing its studies:
Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 450 is above the median of 300 across 107 observational studies indexed under Carcinoma, Transitional Cell.
Median enrollment 71 across the 8 interventional studies, 450 across the 1 observational. Of the 5 that completed or were terminated, 5 (100%) have results posted.
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UroGen Pharma Ltd. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
2 of the studies in Carcinoma, Transitional Cell by UroGen Pharma Ltd. that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06774131Phase 3UroGen Pharma Ltd.A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer | 2027-03 |
| NCT05874921UroGen Pharma Ltd.uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto | 2027-10 |
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Among the 10 studies in Carcinoma, Transitional Cell by UroGen Pharma Ltd., from their registry updates:
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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.
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:
Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with UTUC treated with Jelmyto
Drug: Jelmyto (mitomycin) for pyelocalyceal solution
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.
Also known as: Jelmyto, UGN-101
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
Time frame: 3 months
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
Time frame: 3 years
Recurrence free survival after adjuvant treatment with JEMLYTO
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Time to recurrence
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Time to progression
To evaluate response to JELMYTO treatment in the Registry population
Time frame: 3 years
Incidence of JELMYTO-related AEs
To assess the safety of JELMYTO in the Registry population
Time frame: 3 years
Started Nov 2023 (actual). Primary completion is estimated for Oct 2027, 47 months after the start.
Of 61 observational studies under Carcinoma, Transitional Cell, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 89. This study's planned 47 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Apr 2026 → Oct 2027 and completion Jan 2028 → Oct 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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UroGen Pharma Ltd.