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Active, not recruiting Observational

A Prospective Natural History Study in Uveal Melanoma

NCT04588662 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2021-05-06
Last updated
2026-08-11

Condition(s) studied

Uveal Melanoma

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * 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 Exclusion Criteria \*None

Primary outcome measure(s)

  • Relapse-free Survival Rate — Up to Five years
    Document the relapse-free survival of patients with uveal melanoma from the time of diagnosis of primary disease
  • Overall Survival Rate — Up to Five years
    document the overall survival of patients with uveal melanoma from the time of diagnosis of primary disease
  • Overall Survival Rate of Patients with Uveal Melanoma — Up to Five years
    document the overall survival of patients with uveal melanoma from the time of development of metastatic disease

Trial sites (17)

FacilityCityRegionStatus
Massachusetts General Hospital Boston Massachusetts
Memorial Sloan Kettering Cancer Center New York New York
Thomas Jefferson University Hospital Philadelphia Pennsylvania
MD Anderson Cancer Center Houston Texas
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04588662 on ClinicalTrials.gov ↗ ← All trials in Canada