uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
uTRACT
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
1 other identifier
observational
400
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2023
CompletedStudy Start
First participant enrolled
November 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
ExpectedFebruary 28, 2025
February 1, 2025
2.4 years
December 22, 2022
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of CR or no evidence of disease (NED) at first evaluation post-treatment
3 months
Secondary Outcomes (3)
Duration of response
3 years
Rate of progression
3 years
Rates and clinical significance of AEs
3 years
Study Arms (1)
Jelmyto
Patients with UTUC treated with Jelmyto
Interventions
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.
Eligibility Criteria
Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Providence St. Johns Health Center
Santa Monica, California, 90404, United States
University of Florida
Gainesville, Florida, 32610, United States
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, 33140, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
The State University of Iowa
Iowa City, Iowa, 52242, United States
Chesapeake Urology
Baltimore, Maryland, 21204, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21287, United States
Mass General Hospital (MGH)
Boston, Massachusetts, 02114, United States
The Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Missouri
Columbia, Missouri, 65211, United States
Rutgers
New Brunswick, New Jersey, 08903, United States
The Feinstein Institutes for Medical Research
Lake Success, New York, 11042, United States
NYU Grossman School of Medicine
New York, New York, 10016, United States
SUNY Upstate
Syracuse, New York, 13210, United States
The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Ohio State University
Columbus, Ohio, 43202, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yair Lotan, MD
UT Southwestern Medical Center at Dallas
- PRINCIPAL INVESTIGATOR
Adam Feldman, MD
Massachusett's General Hospital
- PRINCIPAL INVESTIGATOR
Solomon Woldu, MD
UT Southwestern Medical Center at Dallas
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2022
First Posted
May 25, 2023
Study Start
November 17, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
February 28, 2025
Record last verified: 2025-02