Registry for Treatment of Upper Urinary Tract Tumours

Clinical Research Office of the Endourological Society2,451 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,451

Conditions

Upper Urinary Tract Tumours

Eligibility

Sex: ALLMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Amsterdam UMC

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Recurrence rates for patients presenting with primary UTUC stratified for type of treatment

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.

Time frame: 10 years

Secondary Outcomes

Intra- and postoperative complications (including Clavien-Dindo classification)

Time frame: 5 years

Data from ClinicalTrials.gov

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