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

Part of paid clinical trials in Santa Monica, California.

Sponsor
UroGen Pharma Ltd.
Study ID
NCT05874921
Status
Recruiting
Apply to this trial

Conditions

  • Carcinoma, Transitional Cell
  • Transitional Cell Carcinoma of Renal Pelvis
  • Urothelial Cancer of Renal Pelvis
  • Urothelial Carcinoma
  • Urothelial Carcinoma Recurrent
  • Urothelial Carcinoma Ureter
  • Urothelial Carcinoma Ureter Recurrent
  • Urothelial Carcinoma of the Renal Pelvis and Ureter

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Jelmyto (mitomycin) for pyelocalyceal solution — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 17, 2023
Status verified
Feb 2025
Primary completion
Apr 30, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Jelmyto
    Patients with UTUC treated with Jelmyto

Primary Outcome Measure

Rate of CR or no evidence of disease (NED) at first evaluation post-treatment [ Time Frame: 3 months ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Providence St. Johns Health CenterSanta MonicaCalifornia90404
Jennifer Linehan, MD
[email protected]
University of FloridaGainesvilleFlorida32610
Padraic OMalley, MD
Padraic.O'[email protected]
352-265-8240
Mount Sinai Medical Center of Florida, Inc.MiamiFlorida33140
Alan Nieder, MD
[email protected]
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.TampaFlorida33612
Wade Sexton, MD
[email protected]
Northwestern UniversityChicagoIllinois60611
Joshua Meeks, MD
[email protected]
Indiana UniversityIndianapolisIndiana46202
Hristos Kaimakliotis, MD
[email protected]
The State University of IowaIowa CityIowa52242
Michael ODonnell, MD
[email protected]
Chesapeake UrologyBaltimoreMaryland21204
Rian Dickstein, MD
[email protected]
Johns Hopkins Medical CenterBaltimoreMaryland21287
Nirmish Singla, MD
410-955-6100
Mass General Hospital (MGH)BostonMassachusetts02114
Adam Feldman, MD
[email protected]
The Brigham and Womens HospitalBostonMassachusetts02115
Steven Chang, MD
[email protected]
University of MichiganAnn ArborMichigan48109
Khurshid Ghani, MD
[email protected]
University of MissouriColumbiaMissouri65211
Eliza DeFroda, MD
[email protected]
RutgersNew BrunswickNew Jersey08903
Saum Ghodoussipour, MD
[email protected]
The Feinstein Institutes for Medical ResearchLake SuccessNew York11042
David Hoenig, MD
[email protected]
NYU Grossman School of MedicineNew YorkNew York10016
Katie Murray, MD
[email protected]
SUNY UpstateSyracuseNew York13210
Joseph Jacob, MD
[email protected]
The University of North Carolina Chapel HillChapel HillNorth Carolina27599
Marc Bjurlin, MD
[email protected]
Ohio State UniversityColumbusOhio43202
Ahmad Shabsigh, MD
[email protected]
614-685-4263
Medical University of South CarolinaCharlestonSouth Carolina29425
Karthik Tanneru, MD
[email protected]
UT Southwestern Medical CenterDallasTexas75390
Brett Johnson, MD
[email protected]
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Mehrad Adibi, MD
[email protected]

Find similar trials in Santa Monica, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Providence St. Johns Health Center· Santa Monica, CAUniversity of Florida· Gainesville, FLMount Sinai Medical Center of Florida, Inc.· Miami, FLH. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.· Tampa, FLNorthwestern University· Chicago, ILIndiana University· Indianapolis, IN

Related Studies