Retrospective Register for Uveal Melanoma

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 Overview

• Status: Recruiting
• Conditions: Uveal Melanoma
• Intervention / Treatment: Other: any therapy suitable

• Study Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

• Study Contact: Name: Reinhard Told; Phone Number: +4314040048470; Email: reinhard.told@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Reinhard Told, MD, PhD; Phone Number: 48470 +43140400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with uveal melanoma

Description

Inclusion Criteria

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uveal Melanoma	Other: any therapy suitable; any therapy suitable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1997-2021

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: 1942/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No