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

RECRUITINGSponsored by UroGen Pharma Ltd.
Actively Recruiting
SponsorUroGen Pharma Ltd.
Started2023-11-17
Est. completion2026-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations22 sites
View on ClinicalTrials.gov →

NCT05874921

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

Age: 18 Years+Healthy volunteers accepted
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).

Conditions9

CancerCarcinoma, Transitional CellTransitional Cell Carcinoma of Renal PelvisUrothelial Cancer of Renal PelvisUrothelial CarcinomaUrothelial Carcinoma RecurrentUrothelial Carcinoma UreterUrothelial Carcinoma Ureter RecurrentUrothelial Carcinoma of the Renal Pelvis and Ureter

Interventions1

Jelmyto (mitomycin) for pyelocalyceal solution

Locations22 sites

Providence St. Johns Health Center
Santa Monica, California, 90404
Jennifer Linehan, MDJennifer.linehan@providence.org
University of Florida
Gainesville, Florida, 32610
Padraic OMalley, MD352-265-8240Padraic.O'Malley@urology.ufl.edu
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, 33140
Alan Nieder, MDAlan.Nieder@msmc.com
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, 33612
Wade Sexton, MDWade.Sexton@moffitt.org
Northwestern University
Chicago, Illinois, 60611
Joshua Meeks, MDjoshua.meeks@northwestern.edu

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