RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-17
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05874921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of UTUC
  2. 2. Meet at least one of the following criteria:
  3. * Have been treated with Jelmyto after April 2020
  4. * Currently undergoing treatment with Jelmyto
  5. * Will receive Jelmyto
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Anthony Fernandez, PharmD
CONTACT
+1 954-482-3576
registry@urogen.com

Principal Investigator

Yair Lotan, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center at Dallas

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: UroGen Pharma Ltd.

  • Yair Lotan, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center at Dallas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-11-17
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Upper Tract Urothelial Cancer
  • UTUC
  • UGN-101
  • Mitomycin C
  • TCC
  • Ureteral
  • Upper Tract
  • Carcinoma
  • Kidney
  • Renal
  • Gel
  • Local
  • Prolonged Release
  • Slow Release
  • Kidney Sparing
  • Recurrence
  • Neoplasms by Histologic Type
  • Neoplasms
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Neoplasms by Site
  • Antibiotics, Antineoplastic
  • Antineoplastic Agents
  • Alkylating Agents
  • Nucleic Acid Synthesis Inhibitors
  • Enzyme Inhibitors

Additional Relevant MeSH Terms

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