Uveal MelanomaNCT05733728
Retrospective Register for Uveal Melanoma
An observational study of Uveal Melanoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. 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?
- any therapy suitable
- How many people
- 1,400 participants
- Where
- 1 siteAustria
- Study dates
- 23 Jan 2023to 31 Dec 2030
- How long will I take part?
- 10 Years
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with uveal melanoma
Who may be able to join
- Patients 18 - 99 years
- Diagnosis of uveal melanoma Exclusion Criteria
- Patients younger than 18 years of age
- Inadequate or missing information on the clinical course in patient charts
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Reinhard Told, MD, PhD, +43140400 ext. 48470
About this study
Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. Studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs.
Aim: The proposed project is a register for patients with UM treated at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021.
Patients and Methods: Patients treated for UM at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021 will be included in the register. Information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.
- Conditions
- Uveal Melanoma
- Being tested
- any therapy suitable
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
any therapy suitableOther
any therapy suitable
| Study group | Role | What they receive |
|---|---|---|
| Uveal Melanoma | Not described Receives: Other: any therapy suitable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduction of a Register providing the basis for
Retrospective studies analyzing the obtained data and easy identification of patients for prospective studies (e.g. long-term survival analysis)
Measured: 1997-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start23 Jan 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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
- Other
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 10 Years
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733728
- Sponsor's protocol ID
- 1942/2022
- Status last verified
- May 2023
- First submitted
- 8 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Register for Uveal Melanoma
- ClinicalTrials.gov ID
- NCT05733728
- Acronym / sponsor ID
- 1942/2022
- Conditions
- Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Feb 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.
Background: Uveal melanoma (UM) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. Fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. Studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs.
Aim: The proposed project is a register for patients with UM treated at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021.
Patients and Methods: Patients treated for UM at the Department of Ophthalmology and Optometry at the Medical University of Vienna between 01.01.1997 and 31.12.2021 will be included in the register. Information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uveal Melanoma | – | Other: any therapy suitable |
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
Key inclusion criteria (4 listed)
- Patients 18 - 99 years
- Diagnosis of uveal melanoma Exclusion Criteria
- Patients younger than 18 years of age
- Inadequate or missing information on the clinical course in patient charts
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| any therapy suitableany therapy suitable | Other | Uveal Melanoma |
Primary outcome
Conduction of a Register providing the basis for
Time frame: 1997-2021
Retrospective studies analyzing the obtained data and easy identification of patients for prospective studies (e.g. long-term survival analysis)
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 6 May 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.
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 4 inclusion and 0 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 6 May 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 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?
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 Reinhard Told (+4314040048470, 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?
Conduction of a Register providing the basis for (time frame: 1997-2021). 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 May 2023.