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Registry for Treatment of Upper Urinary Tract Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02281188
Recruitment Status : Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : August 5, 2019
Information provided by (Responsible Party):
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.

Condition or disease
Upper Urinary Tract Tumours

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2451 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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 : November 2014
Actual Primary Completion Date : March 12, 2019
Estimated Study Completion Date : March 2024

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intra- and postoperative complications (including Clavien-Dindo classification) [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population comprises those patients presenting with (a) (suspected) primary UUT tumour(s) and are planned to undergo either nephroureterectomy, ureteroscopic diagnostics and/or ureteroscopic treatment, percutaneous treatment or adjuvant treatment in the participating centers.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02281188

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Amsterdam UMC
Amsterdam, Netherlands
Sponsors and Collaborators
Clinical Research Office of the Endourological Society
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Study Chair: Jean de la Rosette Clinical Research Office of the Endourological Society

Additional Information:
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Responsible Party: Clinical Research Office of the Endourological Society Identifier: NCT02281188    
Other Study ID Numbers: Registry UTUC
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site