Clinical trial NCT05874921: uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: 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
Lead sponsor: UroGen Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with UTUC who have been treated, are currently undergoing treatment, or will be treated with JELMYTO.

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.

Detailed 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?

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of CR or no evidence of disease (NED) at first evaluation post-treatment
timeFrame: 3 months
Secondary outcomes:
measure: Duration of response
timeFrame: 3 years
measure: Rate of progression
timeFrame: 3 years
measure: Rates and clinical significance of AEs
timeFrame: 3 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Providence St. Johns Health Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: The State University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Chesapeake Urology
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: The Brigham and Womens Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers
state: New Jersey
city: Lake Success
country: United States
facility: The Feinstein Institutes for Medical Research
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Yair Lotan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusett&amp;#39;s General Hospital
name: Adam Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center at Dallas
name: Solomon Woldu, MD
role: PRINCIPAL_INVESTIGATOR
References: