Upper Urinary Tract TumoursNCT02281188
Registry for Treatment of Upper Urinary Tract Tumours
An observational study of Upper Urinary Tract Tumours, run by Clinical Research Office of the Endourological Society at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Upper Urinary Tract Tumours
- How many people
- 2,451 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Mar 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Is presenting with a suspected primary UTUC (any stage)
- Is scheduled for treatment of UUT tumour
- Has signed informed consent
Who cannot join
- No specific exclusion criteria are defined.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Upper Urinary Tract Tumours
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Intra- and postoperative complications (including Clavien-Dindo classification)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion12 Mar 2019
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Upper Urinary Tract TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,451 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Clinical Research Office of the Endourological Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean de la Rosette, Study chair, Clinical Research Office of the Endourological Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281188
- Sponsor's protocol ID
- Registry UTUC
- Status last verified
- Dec 2020
- First submitted
- 26 Sep 2014
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhao H, Liu K, Ng CF, de la Rosette J, Laguna P, Teoh JY. Oncological Outcomes of Different Managements of the Distal Ureter in Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma. Eur Urol Oncol. 2026 May 28:S2588-9311(26)00135-5. doi: 10.1016/j.euo.2026.05.008. Online ahead of print.
PubMed 42209313Zhao H, Liu K, Crisci A, Te Slaa E, Habuchi T, Akand M, Ng CF, Laguna P, Teoh JY, de la Rosette J. Impact of smoking status at diagnosis on oncological outcomes of upper-tract urothelial carcinoma. Ther Adv Urol. 2025 Jun 28;17:17562872251352049. doi: 10.1177/17562872251352049. eCollection 2025 Jan-Dec.
PubMed 40584958Liu K, Leung DK, Wong CH, Ko IC, Horuz R, Gontero P, Laguna P, de la Rosette J, Teoh JY. Influence of tumour location on the survival outcomes of upper tract urothelial carcinoma treated with radical nephroureterectomy. World J Urol. 2025 May 3;43(1):261. doi: 10.1007/s00345-024-05432-0.
PubMed 40317391Liu K, Wong CH, Zhao H, Ng CF, Teoh JY, Laguna P, de la Rosette J. Impact of Antiaggregant and Anticoagulant Medications on Perioperative Complications in Upper Tract Urothelial Carcinoma. Eur Urol Open Sci. 2025 Mar 20;75:1-6. doi: 10.1016/j.euros.2025.02.007. eCollection 2025 May.
PubMed 40206439Liu K, Zhao H, Ng CF, Teoh JYC, Laguna P, de la Rosette J. Kidney-Sparing Surgery Has Equivalent Oncological Outcomes to Radical Nephroureterectomy for Ureteral Urothelial Carcinoma. J Endourol. 2024 Sep;38(9):921-928. doi: 10.1089/end.2024.0061. Epub 2024 Jun 11.
PubMed 38756081Baard J, Cormio L, Dasgupta R, Maruzzi D, Rais-Bahrami S, Serrano A, Geavlete B, Giannakopoulos S, de la Rosette J, Laguna P. Unveiling the challenges of UTUC biopsies and cytology: insights from a global real-world practice study. World J Urol. 2024 Mar 20;42(1):177. doi: 10.1007/s00345-024-04866-w.
PubMed 38507109Baard J, Shariat SF, Roupret M, Yoshida T, Saita A, Saltirov I, Burgos JR, Celik O, de la Rosette J, Laguna P. Adherence to guideline recommendations in the management of upper tract urothelial carcinoma: an analysis of the CROES-UTUC registry. World J Urol. 2022 Nov;40(11):2755-2763. doi: 10.1007/s00345-022-04168-z. Epub 2022 Oct 5.
PubMed 36197507Baard J, Cormio L, Cavadas V, Alcaraz A, Shariat SF, de la Rosette J, Laguna MP. Contemporary patterns of presentation, diagnostics and management of upper tract urothelial cancer in 101 centres: the Clinical Research Office of the Endourological Society Global upper tract urothelial carcinoma registry. Curr Opin Urol. 2021 Jul 1;31(4):354-362. doi: 10.1097/MOU.0000000000000899.
PubMed 34009177Baard J, Celebi M, de la Rosette J, Alcaraz A, Shariat S, Cormio L, Cavadas V, Laguna MP. Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter, Cohort Study by the Clinical Research Office of the Endourology Society. JMIR Res Protoc. 2020 Jan 24;9(1):e15363. doi: 10.2196/15363.
PubMed 32012106
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02281188
- Acronym / sponsor ID
- Registry UTUC
- Conditions
- Upper Urinary Tract Tumours
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,451 participants (actual)
- Lead sponsor
- Clinical Research Office of the Endourological SocietyUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Is presenting with a suspected primary UTUC (any stage)
- Is scheduled for treatment of UUT tumour
- Has signed informed consent
Key exclusion criteria (1 listed)
- No specific exclusion criteria are defined.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Intra- and postoperative complications (including Clavien-Dindo classification)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 42209313Zhao H, Liu K, Ng CF, de la Rosette J, Laguna P, Teoh JY. Oncological Outcomes of Different Managements of the Distal Ureter in Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma. Eur Urol Oncol. 2026 May 28:S2588-9311(26)00135-5. doi: 10.1016/j.euo.2026.05.008. Online ahead of print.
- Derived from this study: PubMed 40584958Zhao H, Liu K, Crisci A, Te Slaa E, Habuchi T, Akand M, Ng CF, Laguna P, Teoh JY, de la Rosette J. Impact of smoking status at diagnosis on oncological outcomes of upper-tract urothelial carcinoma. Ther Adv Urol. 2025 Jun 28;17:17562872251352049. doi: 10.1177/17562872251352049. eCollection 2025 Jan-Dec.
- Derived from this study: PubMed 40317391Liu K, Leung DK, Wong CH, Ko IC, Horuz R, Gontero P, Laguna P, de la Rosette J, Teoh JY. Influence of tumour location on the survival outcomes of upper tract urothelial carcinoma treated with radical nephroureterectomy. World J Urol. 2025 May 3;43(1):261. doi: 10.1007/s00345-024-05432-0.
- Derived from this study: PubMed 40206439Liu K, Wong CH, Zhao H, Ng CF, Teoh JY, Laguna P, de la Rosette J. Impact of Antiaggregant and Anticoagulant Medications on Perioperative Complications in Upper Tract Urothelial Carcinoma. Eur Urol Open Sci. 2025 Mar 20;75:1-6. doi: 10.1016/j.euros.2025.02.007. eCollection 2025 May.
- Derived from this study: PubMed 38756081Liu K, Zhao H, Ng CF, Teoh JYC, Laguna P, de la Rosette J. Kidney-Sparing Surgery Has Equivalent Oncological Outcomes to Radical Nephroureterectomy for Ureteral Urothelial Carcinoma. J Endourol. 2024 Sep;38(9):921-928. doi: 10.1089/end.2024.0061. Epub 2024 Jun 11.
- Derived from this study: PubMed 38507109Baard J, Cormio L, Dasgupta R, Maruzzi D, Rais-Bahrami S, Serrano A, Geavlete B, Giannakopoulos S, de la Rosette J, Laguna P. Unveiling the challenges of UTUC biopsies and cytology: insights from a global real-world practice study. World J Urol. 2024 Mar 20;42(1):177. doi: 10.1007/s00345-024-04866-w.
- Derived from this study: PubMed 36197507Baard J, Shariat SF, Roupret M, Yoshida T, Saita A, Saltirov I, Burgos JR, Celik O, de la Rosette J, Laguna P. Adherence to guideline recommendations in the management of upper tract urothelial carcinoma: an analysis of the CROES-UTUC registry. World J Urol. 2022 Nov;40(11):2755-2763. doi: 10.1007/s00345-022-04168-z. Epub 2022 Oct 5.
- Derived from this study: PubMed 34009177Baard J, Cormio L, Cavadas V, Alcaraz A, Shariat SF, de la Rosette J, Laguna MP. Contemporary patterns of presentation, diagnostics and management of upper tract urothelial cancer in 101 centres: the Clinical Research Office of the Endourological Society Global upper tract urothelial carcinoma registry. Curr Opin Urol. 2021 Jul 1;31(4):354-362. doi: 10.1097/MOU.0000000000000899.
- Derived from this study: PubMed 32012106Baard J, Celebi M, de la Rosette J, Alcaraz A, Shariat S, Cormio L, Cavadas V, Laguna MP. Evaluation of Patterns of Presentation, Practice, and Outcomes of Upper Tract Urothelial Cancer: Protocol for an Observational, International, Multicenter, Cohort Study by the Clinical Research Office of the Endourology Society. JMIR Res Protoc. 2020 Jan 24;9(1):e15363. doi: 10.2196/15363.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean de la Rosette study chair
Clinical Research Office of the Endourological Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Urinary Tract Tumours, run by Clinical Research Office of the Endourological Society at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rates for patients presenting with primary UTUC stratified for type of treatment (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281188, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.