Upper Urinary Tract Urothelial CarcinomaNCT06169436
Translational Cancer Observational Protocol
An observational study of Upper Urinary Tract Urothelial Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Urinary Tract Urothelial Carcinoma
- What is being tested?
- Nephroureterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,250 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2014to 17 Jul 2064
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with upper tract urothelial cancer who underwent nephroureterectomy surgery.
Who may be able to join
- 18 years or older
- Upper tract urothelial cancer diagnosis
- Indication to cancer removal through nephroureterectomy surgery
- Ability to read and sign the informed consent
Who cannot join
- Age < 18 years
- Absence of upper tract urothelial cancer
- Inability to read and sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Francesco Fiorio, MSC, 02 2643 6268, fiorio.francesco@hsr.it
About this study
Official title: 2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery
Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery
Read the detailed description
Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.
- Conditions
- Upper Urinary Tract Urothelial Carcinoma
- Being tested
- Nephroureterectomy
- Keywords
- Upper Urinary Tract Urothelial Carcinoma, Nephroureterectomy surgery, Relapse, Quality of life, Diagnosis and Treatment strategies
- Medical subject headings
- Recurrence, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NephroureterectomyProcedure or surgery
Removal of cancer mass by urether and kidney complete resection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery Receives: Procedure: Nephroureterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical progression data collection
Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams.
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start17 Jul 2014
- Primary completion17 Jul 2064 (estimated)
- Study completion17 Jul 2064 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Urinary Tract Urothelial CarcinomaStudies 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
- Other
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Montorsi, IRCCS San Raffaele
- Investigators
- Francesco Montorsi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169436
- Sponsor's protocol ID
- 2014 - Transizionali
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery
- ClinicalTrials.gov ID
- NCT06169436
- Acronym / sponsor ID
- 2014 - Transizionali
- Conditions
- Upper Urinary Tract Urothelial Carcinoma
- Keywords
- Upper Urinary Tract Urothelial Carcinoma, Nephroureterectomy surgery, Relapse, Quality of life, Diagnosis and Treatment strategies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 17 Jul 2014 (actual)
- Primary completion
- 17 Jul 2064 (estimated)
- Study completion
- 17 Jul 2064 (estimated)
- First posted
- 13 Dec 2023 (actual)
- 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.
Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery
Detailed description
Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Procedure: NephroureterectomyPatients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with upper tract urothelial cancer who underwent nephroureterectomy surgery.
Key inclusion criteria (4 listed)
- 18 years or older
- Upper tract urothelial cancer diagnosis
- Indication to cancer removal through nephroureterectomy surgery
- Ability to read and sign the informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- Absence of upper tract urothelial cancer
- Inability to read and sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NephroureterectomyRemoval of cancer mass by urether and kidney complete resection. | Procedure or surgery | Experimental |
Primary outcome
Clinical progression data collection
Time frame: 50 years
Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Francesco Montorsi, MD principal investigator
IRCCS Ospedale San Raffaele
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 Urothelial Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Dec 2023. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Montorsi, MD. (02 2643 7286, montorsi.francesco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical progression data collection (time frame: 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.