Registry for Treatment of Upper Urinary Tract Tumours

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.

Full Title of Study: “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

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 12, 2019

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.

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence rates for patients presenting with primary UTUC stratified for type of treatment
    • Time Frame: 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 Measures

  • Intra- and postoperative complications (including Clavien-Dindo classification)
    • Time Frame: 5 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinical Research Office of the Endourological Society
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean de la Rosette, Study Chair, Clinical Research Office of the Endourological Society

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.