Clinical trial NCT02281188: Registry for Treatment of Upper Urinary Tract Tumours
Official title: Registry for Treatment of Upper Urinary Tract Tumours; A Multi-Center, International Registry to Evaluate the Treatment of Upper Tract Urothelial Cancer: Incidence, Indications, Treatment Types and Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Urinary Tract Tumours
Lead sponsor: Clinical Research Office of the Endourological Society
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 2451
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises those patients presenting with (a) (suspected) primary UUT tumour(s) and are planned to undergo either nephroureterectomy, ureteroscopic diagnostics and/or ureteroscopic treatment, percutaneous treatment or adjuvant treatment in the participating centers.

Brief summary: The aim of this registry is to evaluate the incidence, indications and outcomes of patients presenting with UTUC in relation to the different treatment modalities used.

Detailed description: This is an observational international multi-center study in which data on consecutive patients with UUT tumours are collected. Centers from every continent may apply for participation in this registry. Data will be collected from consecutive patients over a five year period. Patients' data at baseline visit, at one year, three years and five years after inclusion in the registry will be recorded, as well as data on intra- and postoperative complications, recurrence and survival in the whole study period. Data from all participating centers will be collected through electronic case report forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office.

Eligibility criteria: Inclusion Criteria:

* Is presenting with a suspected primary UTUC (any stage)
* Is scheduled for treatment of UUT tumour
* Has signed informed consent

Exclusion Criteria:

* No specific exclusion criteria are defined.

Primary outcomes:
measure: Recurrence rates for patients presenting with primary UTUC stratified for type of treatment
timeFrame: 10 years
Secondary outcomes:
measure: Intra- and postoperative complications (including Clavien-Dindo classification)
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Clinical Research Office of the Endourological Society
name: Jean de la Rosette
role: STUDY_CHAIR
References:
citation: Baard J, Shariat SF, Roupret M, Yoshida T, Saita A, Saltirov I, Burgos JR, Celik O, de la Rosette J, Laguna P. Adherence to guideline recommendations in the management of upper tract urothelial carcinoma: an analysis of the CROES-UTUC registry. World J Urol. 2022 Nov;40(11):2755-2763. doi: 10.1007/s00345-022-04168-z. Epub 2022 Oct 5.
citation: Baard J, Cormio L, Cavadas V, Alcaraz A, Shariat SF, de la Rosette J, Laguna MP. Contemporary patterns of presentation, diagnostics and management of upper tract urothelial cancer in 101 centres: the Clinical Research Office of the Endourological Society Global upper tract urothelial carcinoma registry. Curr Opin Urol. 2021 Jul 1;31(4):354-362. doi: 10.1097/MOU.0000000000000899.
citation: Baard J, Celebi M, de la Rosette J, Alcaraz A, Shariat S, Cormio L, Cavadas V, Laguna MP. Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter, Cohort Study by the Clinical Research Office of the Endourology Society. JMIR Res Protoc. 2020 Jan 24;9(1):e15363. doi: 10.2196/15363.