Urologic DiseasesNCT04763538
Quality and Outcome Measurements of Urological Patients
An observational study of Urologic Diseases, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. Upon a given samples size, neuronal networks will be trained to define clinical endpoints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases
- How many people
- 2,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2021to 30 Apr 2028
- 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: Entire patient population that is treated at the study sites
Who may be able to join
- All patients treated at the study sites, signed informed consent
Who cannot join
- No consent to record medical history
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Roland Seiler
Biel, 2501
Roland Seiler, Prof., +41 32 324 24 24, r_seiler@gmx.ch
- Recruiting
Department of Urology, Hospital Center Biel
Biel
Roland Seiler, MD, +41 32 324 32 06
About this study
Prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. Upon a given samples size, neuronal networks will be trained to define clinical endpoints. Beside uro-oncological patients also patients with other urological diseases will be enrolled.
- Conditions
- Urologic Diseases
- Being tested
- Standard of care
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Patients are treated according to the standard of care for each individual disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific primary endpoint
Neuronal networks will be trained to define the respective endpoints for the diseases
Measured: 4-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Centre Biel/Bienne
- Responsible party
- Sponsor
- Investigators
- Roland Seiler, Prof., Study chair, Department of Urology, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763538
- Sponsor's protocol ID
- ID 2020-02852
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this trial, the investigators will record complete patient data in our multilayered databases. They will be used to train neuronal networks. Latter can be shared with researchers, the multilayered databases will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Outcome Measurements of Urological Patients
- ClinicalTrials.gov ID
- NCT04763538
- Acronym / sponsor ID
- ID 2020-02852
- Conditions
- Urologic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Hospital Centre Biel/Bienne
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Feb 2021 (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.
Prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. Upon a given samples size, neuronal networks will be trained to define clinical endpoints. Beside uro-oncological patients also patients with other urological diseases will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Entire patient population that is treated at the study sites
Key inclusion criteria (1 listed)
- All patients treated at the study sites, signed informed consent
Key exclusion criteria (1 listed)
- No consent to record medical history
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 |
|---|---|---|
| Standard of carePatients are treated according to the standard of care for each individual disease. | Other | – |
Primary outcome
Disease specific primary endpoint
Time frame: 4-5 years
Neuronal networks will be trained to define the respective endpoints for the diseases
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 10 Mar 2023.
- Individual participant dataSharing planned: No. In this trial, the investigators will record complete patient data in our multilayered databases. They will be used to train neuronal networks. Latter can be shared with researchers, the multilayered databases will not be shared.
Related trials for Urologic Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
Roland Seiler, Prof. study chair
Department of Urology, University Hospital Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 1 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: looking for participants now, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 Roland Seiler, Prof. (+41316321349, Roland.Seiler@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease specific primary endpoint (time frame: 4-5 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 10 Mar 2023.