uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

Last updated: February 25, 2025
Sponsor: UroGen Pharma Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Renal Cancer

Urothelial Carcinoma

Treatment

Jelmyto (mitomycin) for pyelocalyceal solution

Clinical Study ID

NCT05874921
UT004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Incapable of giving informed consent (e.g., incarcerated individuals, individualswith dementia).

  • Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel inclinical 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 Registryinadvisable in the opinion of the Investigator (for prospective data capture).

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Jelmyto (mitomycin) for pyelocalyceal solution
Phase:
Study Start date:
November 17, 2023
Estimated Completion Date:
January 31, 2028

Study 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?

Connect with a study center

  • Providence St. Johns Health Center

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Mount Sinai Medical Center of Florida, Inc.

    Miami, Florida 33140
    United States

    Active - Recruiting

  • H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • The State University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Chesapeake Urology

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Johns Hopkins Medical Center

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Mass General Hospital (MGH)

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • The Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Missouri

    Columbia, Missouri 65211
    United States

    Active - Recruiting

  • Rutgers

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • The Feinstein Institutes for Medical Research

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • NYU Grossman School of Medicine

    New York, New York 10016
    United States

    Active - Recruiting

  • SUNY Upstate

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • The University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43202
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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