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Registry for Treatment of Upper Urinary Tract Tumours

Sponsor
Clinical Research Office of the Endourological Society (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02281188
Collaborator
(none)
2,451
Enrollment
1
Location
112
Anticipated Duration (Months)
21.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    2451 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Mar 12, 2019
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Intra- and postoperative complications (including Clavien-Dindo classification) [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amsterdam UMC Amsterdam Netherlands

    Sponsors and Collaborators

    • Clinical Research Office of the Endourological Society

    Investigators

    • Study Chair: Jean de la Rosette, Clinical Research Office of the Endourological Society

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Clinical Research Office of the Endourological Society
    ClinicalTrials.gov Identifier:
    NCT02281188
    Other Study ID Numbers:
    • Registry UTUC
    First Posted:
    Nov 2, 2014
    Last Update Posted:
    Dec 14, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Urologic Neoplasms

    Study Results

    No Results Posted as of Dec 14, 2020