A Prospective Natural History Study in Uveal Melanoma

Uveal Melanoma Clinical Trial

Official title:

A Prospective Natural History Study in Uveal Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588662
• Other study ID #: AAAR5976
• Status: Recruiting
• Start date: May 6, 2021
• Est. completion date: July 2026

Study information

• Verified date: June 2023
• Source: Columbia University
• Contact: Research Nurse Navigator
• Phone: 212-342-5162
• Email: cancerclinicaltrials[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Locations

Country	Name	City	State
Australia	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
Canada	Princess Margaret Cancer Center	Toronto
Germany	Erlangen	Erlangen
United Kingdom	Clatterbridge Cancer Centre	Birkenhead
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Sheffield	Sheffield
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall Survival Rate	document the overall survival of patients with uveal melanoma from the time of diagnosis of primary disease	Up to Five years
Primary	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