Melanoma Clinical Trial

A Prospective Natural History Study in Uveal Melanoma

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Estimated Enrollment:

700

Study ID:

NCT04588662

Recruitment Status:

Recruiting

Sponsor:

Columbia University

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There are 4 Locations for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Ryan Sulivan, MD
Contact
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Alex Shoushtari, MD
Contact
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Marlana Orloff, MD
Contact
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Sapna Patel, MD
Contact
Royal Adelaide Hospital
Adelaide , , Australia More Info
David Sia, MD
Contact
Chatswood Eye Specialists
Chatswood , , Australia More Info
Michael Giblin, MD
Contact
Royal Victorian Eve and Ear Hospital
East Melbourne , , Australia More Info
John Mckenzie, MD
Contact
Western Eye Specialists
Maribyrnong , , Australia More Info
Roderick O'Day, MD
Contact
Pennington Eye Clinic
North Adelaide , , Australia More Info
David Sia, MD
Contact
Perth Retina
Subiaco , , Australia More Info
Tim Isaacs, MD
Contact
Dr. Conway Private Rooms
Sydney , , Australia More Info
Max Conway, MD
Contact
St. Vincent's Hospital
Sydney , , Australia More Info
Anthony Joshua, MD
Contact
Princess Margaret Cancer Center
Toronto , , Canada More Info
Marcus Bulter, MD
Contact
Erlangen
Erlangen , , Germany More Info
Markus Heppt, MD
Contact
Clatterbridge Cancer Centre
Birkenhead , , United Kingdom More Info
Joseph Sacco, MD
Contact
Mount Vernon Cancer Centre
Northwood , , United Kingdom More Info
Heather Shaw, MD
Contact
Sheffield
Sheffield , , United Kingdom More Info
Shobaha Silva, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

700

Study ID:

NCT04588662

Recruitment Status:

Recruiting

Sponsor:


Columbia University

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