A Prospective Natural History Study in Uveal Melanoma
1 other identifier
observational
122
5 countries
17
Brief Summary
The overall objective of this proposal is to develop and utilize a multicenter UM registry that will, in a longitudinal fashion, capture prospective data in order to characterize the natural history of UM and provide data that will be used to support the development of novel therapies for this disease. The care of patients with UM requires a multi-disciplinary team of physicians that commonly requires the involvement of both radiation oncology and interventional radiology, and is typically directed by an ophthalmologic oncologist at time of initial diagnosis of primary disease. Overall management is transitioned to a medical oncologist when distant recurrence is identified. In the case that a patient presents with metastasis at the time of diagnosis, a medical oncologist typically directs overall management. The management of surveillance for the development of metastasis following the treatment of primary disease is variable and, if performed at all, is managed by either an ophthalmologic oncologist or medical oncologist. Thus, the successful development of a registry that aims to capture the data regarding the full natural history of UM requires a collaborative effort including leaders from both the UM ophthalmologic oncology and medical oncology fields. To this end, the investigators have built an initial consortium of key ophthalmologic oncology and medical oncology leaders from multiple major UM centers in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
CompletedAugust 22, 2025
August 1, 2025
5.2 years
July 16, 2020
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Relapse-free Survival Rate
Document the relapse-free survival of patients with uveal melanoma from the time of diagnosis of primary disease
Up to Five years
Overall Survival Rate
document the overall survival of patients with uveal melanoma from the time of diagnosis of primary disease
Up to Five years
Overall Survival Rate of Patients with Uveal Melanoma
document the overall survival of patients with uveal melanoma from the time of development of metastatic disease
Up to Five years
Study Arms (1)
Uveal Melanoma
Diagnosis of uveal melanoma Ability to provide written informed consent for participation in the prospective registry OR an institutional waiver by the IRB/ethics committee for retrospective data collection without written informed consent
Eligibility Criteria
* Diagnosis of uveal melanoma * Male/Female over the age of 18 years of age
You may qualify if:
- Diagnosis of uveal melanoma
- Ability to provide written informed consent for participation in the prospective registry OR an institutional waiver by the IRB/ethics committee for retrospective data collection without written informed consent
You may not qualify if:
- \*None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Royal Adelaide Hospital
Adelaide, Australia
Chatswood Eye Specialists
Chatswood, Australia
Royal Victorian Eve and Ear Hospital
East Melbourne, Australia
Western Eye Specialists
Maribyrnong, Australia
Pennington Eye Clinic
North Adelaide, Australia
Perth Retina
Subiaco, Australia
Dr. Conway Private Rooms
Sydney, Australia
St. Vincent's Hospital
Sydney, Australia
Princess Margaret Cancer Center
Toronto, Canada
Erlangen
Erlangen, Germany
Clatterbridge Cancer Centre
Birkenhead, United Kingdom
Mount Vernon Cancer Centre
Northwood, United Kingdom
Sheffield
Sheffield, United Kingdom
Biospecimen
Residual tissue samples from clinical care biopsies that would otherwise be discarded will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariam El-Ashmawy, MD, PhD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2020
First Posted
October 19, 2020
Study Start
May 6, 2021
Primary Completion
July 1, 2026
Study Completion
July 1, 2026
Last Updated
August 22, 2025
Record last verified: 2025-08