Clinical trial · Observational
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
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
NCT05874921CI-TRIAL-00086618uTRACTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Transitional Cell | Transitional Cell Carcinoma | ALIAS | 0.90 |
| Transitional Cell Carcinoma of Renal Pelvis | Renal Pelvis Urothelial Carcinoma | ALIAS | 0.90 |
| Urothelial Cancer of Renal Pelvis | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma of the Renal Pelvis and Ureter | Renal Pelvis and Ureter Urothelial Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma Recurrent | — | UNRESOLVED | — |
| Urothelial Carcinoma Ureter | — | UNRESOLVED | — |
| Urothelial Carcinoma Ureter Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jelmyto (mitomycin) for pyelocalyceal solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Jelmyto
- description
- Patients with UTUC treated with Jelmyto
- interventionNames
- Drug: Jelmyto (mitomycin) for pyelocalyceal solution
Primary outcomes (1)
- measure
- Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)
- timeFrame
- 3 months
- description
- To evaluate the tumor ablative effect of JELMYTO in the Registry population
Secondary outcomes (5)
- measure
- Durability of response at 12, 24, and 36 months in patients who achieve NED after primary treatment with JELMYTO.
- timeFrame
- 3 years
- description
- To evaluate response to JELMYTO treatment in the Registry population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.