Uveal MelanomaNCT06280040
Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
An observational study of Uveal Melanoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Clinical examination and multimodal ocular imaging
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 23 Nov 2023to 30 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study.
Who may be able to join
- Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine.
Who cannot join
- unwillingness to participate in the study
- severe media opacity
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Ophthalmology and Optometry, Medical University Vienna
Vienna, 1090
Judith Kreminger, MD, 0043 1 40400 48470, judith.kreminger@meduniwien.ac.at
Reinhard Told, MD, PhD, Priv.-Doz., 0043 1 40400 48470, reinhard.told@meduniwien.ac.at
About this study
Official title: Longitudinal Follow-Up of Retinopathy and Opticopathy After Treatment With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.
- Conditions
- Uveal Melanoma
- Being tested
- Clinical examination and multimodal ocular imaging
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination and multimodal ocular imagingDiagnostic test
Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.
| Study group | Role | What they receive |
|---|---|---|
| Uveal Melanoma | Patients with newly diagnosed uveal melanoma, which will be treated with hypofractionated stereotactic photon radiotherapy as clinical routine. Receives: Diagnostic Test: Clinical examination and multimodal ocular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Retinopathy
Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography
Measured: 1 year
Secondary outcomes (3)
Incidence and Severity of Opticopathy
Incidence and severity of retinopathy will be evaluated on clinical examination and fundus photography
Measured: 1 year
Functional Outcome
Functional outcome will be evaluated as mean retinal sensitivity.
Measured: 1 year
Incidence and Severity of Retinopathy and Opticopathy in oximeter
Incidence and severity of retinopathy and opticopathy will be evaluated using oxygen saturation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (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
- 20 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, Principal investigator, Department for Ophthalmology and Optometry, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280040
- Sponsor's protocol ID
- UM Longitudinal 1942/2022
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-Up of Retinopathy and Opticopathy After Treatment With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
- ClinicalTrials.gov ID
- NCT06280040
- Acronym / sponsor ID
- UM Longitudinal 1942/2022
- Conditions
- Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 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 purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uveal Melanoma | – | Diagnostic Test: Clinical examination and multimodal ocular imagingPatients with newly diagnosed uveal melanoma, which will be treated with hypofractionated stereotactic photon radiotherapy as clinical routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study.
Key inclusion criteria (1 listed)
- Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine.
Key exclusion criteria (2 listed)
- unwillingness to participate in the study
- severe media opacity
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 |
|---|---|---|
| Clinical examination and multimodal ocular imagingImaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry. | Diagnostic test | Uveal Melanoma |
Primary outcome
Incidence and Severity of Retinopathy
Time frame: 1 year
Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography
3 secondary outcomes
Incidence and Severity of Opticopathy
Time frame: 1 year
Functional Outcome
Time frame: 1 year
Incidence and Severity of Retinopathy and Opticopathy in oximeter
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Department for Ophthalmology and Optometry, Medical University of Vienna
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 6 Mar 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 Judith Kreminger, MD (0043 1 40400 48470, judith.kreminger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Retinopathy (time frame: 1 year). 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 6 Mar 2024.