Registry for Treatment of Upper Urinary Tract Tumours

• Conditions: Upper Urinary Tract Tumours

• Registration Number: NCT02281188
• Lead Sponsor: Clinical Research Office of the Endourological Society

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.

Study Timeline

• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-10-30
• Study Start: 2014-11
• Study First Posted: 2014-11-02
• Primary Completion: 2019-03-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2451

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rates for patients presenting with primary UTUC stratified for type of treatment	10 years	Data collection will be divided into the following categories: Patient / tumour characteristics, assessment, treatment choice and intra-operative details, post-operative details and complications, and follow up. The following lists all categories and type of data to be gathered.; Patient characteristics: demographics, risk factors, comorbidities and previous malignancies.; Assessment: symptoms, imaging type, cytology, TNM staging. Treatment choice and intra-operative details: date, use of endoscopy, type of scopes, type of imaging enhancement, biopsies, results, neo adjuvant treatment specifications and treatment type.; Intra-operative: date, duration, antibiotics, type of treatment, results. Post-operative: complications and Clavien-Dindo classification, instillation, adjuvant therapy, pathology.; Follow up: date, status (e.g. alive without cancer, alive with cancer), recurrence, diagnostics performed, cystoscopy, cytology, results.

Secondary Outcome Measures

Name	Time	Method
Intra- and postoperative complications (including Clavien-Dindo classification)	5 years

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands