Registry for Treatment of Upper Urinary Tract Tumours

Upper Urinary Tract Tumours Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02281188
• Other study ID #: Registry UTUC
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: March 2024

Study information

• Verified date: December 2020
• Source: Clinical Research Office of the Endourological Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2451
• Est. completion date: March 2024
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Upper Urinary Tract Tumours
• Urologic Neoplasms

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Office of the Endourological Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years
Secondary	Intra- and postoperative complications (including Clavien-Dindo classification)		5 years

External Links

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