A Prospective Natural History Study in Uveal Melanoma

Study Overview
=================
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.

Official Title
-----------------
A Prospective Natural History Study in Uveal Melanoma

Conditions
-----------------
Uveal Melanoma

Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uveal Melanoma<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveal Melanoma