Uveal MelanomaNCT06284512
Uveal Melanoma - Comparative Study
An observational study of Uveal Melanoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Sonography, color fundus photography
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 15 Oct 2023to 31 Dec 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with uveal melanoma will be included in this study.
Who may be able to join
- Diagnosis of uveal melanoma
Who cannot join
- Inadequate or missing information on the clinical course in patient charts
- Imaging not feasible due to any reason.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, 1090
Judith Kreminger, MD, +4314040048470, judith.kreminger@meduniwien.ac.at
Reinhard Told, MD, PhD, Priv.-Doz., +434040079690, reinhard.told@meduniwien.ac.at
About this study
Official title: Uveal Melanoma In Sonography and Color Fundus Photos - A Comparative Study
The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.
- Conditions
- Uveal Melanoma
- Being tested
- Sonography, color fundus photography
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonography, color fundus photographyDiagnostic test
Patients will undergo routine diagnostic imaging (Sonography, color fundus photography)
| Study group | Role | What they receive |
|---|---|---|
| Uveal Melanoma | Patients with uveal melanoma will undergo a routine diagnostic imaging with color fundus photography and sonography. Receives: Diagnostic Test: Sonography, color fundus photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Largest Basal Diameter
Largest Basal Diameter will be measured on echography and color fundus photography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhard Told, Medical University of Vienna
- Investigators
- Reinhard Told, MD, PhD, Priv.-Doz., Principal investigator, Deparment of Ophthalmology and Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284512
- Sponsor's protocol ID
- Uveal Melanoma 1942/2022
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2023
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uveal Melanoma In Sonography and Color Fundus Photos - A Comparative Study
- ClinicalTrials.gov ID
- NCT06284512
- Acronym / sponsor ID
- Uveal Melanoma 1942/2022
- Conditions
- Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Feb 2024 (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.
The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uveal Melanoma | – | Diagnostic Test: Sonography, color fundus photographyPatients with uveal melanoma will undergo a routine diagnostic imaging with color fundus photography and sonography. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uveal melanoma will be included in this study.
Key inclusion criteria (1 listed)
- Diagnosis of uveal melanoma
Key exclusion criteria (2 listed)
- Inadequate or missing information on the clinical course in patient charts
- Imaging not feasible due to any reason.
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 |
|---|---|---|
| Sonography, color fundus photographyPatients will undergo routine diagnostic imaging (Sonography, color fundus photography) | Diagnostic test | Uveal Melanoma |
Primary outcome
Largest Basal Diameter
Time frame: 1 day
Largest Basal Diameter will be measured on echography and color fundus photography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- 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. This study is not recruiting at the moment.
Reinhard Told, MD, PhD, Priv.-Doz. principal investigator
Deparment of Ophthalmology and Optometry
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 Uveal Melanoma, run by Medical University of Vienna at 1 site in Austria.
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 2 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 29 Feb 2024. 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 Austria. 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?
Contact Reinhard Told, MD, PhD, Priv.-Doz. (+43 40400 79690, reinhard.told@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Largest Basal Diameter (time frame: 1 day). 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 29 Feb 2024.