uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Jelmyto (mitomycin) for pyelocalyceal solution.
- Who it may be relevant to
- Registry conditions: Urothelial Carcinoma, Urothelial Carcinoma Recurrent, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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:
1. How is Jelmyto used in the real world setting? 2. What adverse events (AEs) and at what rates and time points are they observed in the real world setting? 3. What is the disease volume before and after resection/ablation prior to treating with Jelmyto? 4. Did the use of Jelmyto impact clinical decision making and management? 5. What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest? 6. What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received? 7. 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? 8. 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? 9. What is the rate and timing of bladder cancer occurrence and/or recurrences?
Interventions
- 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.
Primary outcome measures
- Rate of CR or no evidence of disease (NED) at first evaluation post-treatment [Time frame: 3 months]
Secondary outcome measures (3)
- Duration of response [Time frame: 3 years]
- Rate of progression [Time frame: 3 years]
- Rates and clinical significance of AEs [Time frame: 3 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 22 centers
- Providence St. Johns Health Center — Santa Monica
- University of Florida — Gainesville
- Mount Sinai Medical Center of Florida, Inc. — Miami
- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. — Tampa
- Northwestern University — Chicago
- Indiana University — Indianapolis
- The State University of Iowa — Iowa City
- Chesapeake Urology — Baltimore
- … and 14 more centers
Identifiers
NCT: NCT05874921 · UT004