A Prospective Natural History Study in Uveal Melanoma

NCT ID: NCT04588662

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2026-07-31

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.

Detailed Description

Uveal melanoma (UM) is the most common primary intraocular malignancy in adults, accounting for 85% to 95% of ocular melanoma cases. However, UM represents only about 3% to 5% of all melanomas in the United States (US). UM most commonly arises from choroidal melanocytes (85-90%), but can also arise from the iris (3-5%) and ciliary body (5-8%). The median age of diagnosis is approximately 62; however, the peak range for diagnosis is between 70 and 79. Males have a 30% greater incidence than females. A variety of putative risk factors have been identified, including the presence of light eyes, fair skin, an inability to tan, ocular melanocytosis, dysplastic nevus syndrome, and germline BRCA1-associated protein 1 (BAP1) mutations.

Importantly, there are no recent or on-going multi-center natural history studies being conducted in this disease, and this effort is the only one to be launched with the goal of capturing the complete course of this disease, from diagnosis, initial management, surveillance, and treatment of recurrent disease in a national and international setting. This registry is especially important in providing such needed data.

Conditions

Uveal Melanoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariam El-Ashmawy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, 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

Countries

United States; Australia; Canada; Germany; United Kingdom

Other Identifiers

AAAR5976

Identifier Type: -

Identifier Source: org_study_id