Brief Title
A Prospective Natural History Study in Uveal Melanoma
Official Title
A Prospective Natural History Study in Uveal Melanoma
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Relapse-free Survival Rate
Condition
Uveal Melanoma
Study Arms / Comparison Groups
Uveal Melanoma
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
700
Start Date
November 2021
Completion Date
July 2023
Primary Completion Date
July 2023
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Richard D. Carvajal, MD, 212-342-5162, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04588662
Organization ID
AAAR5976
Responsible Party
Sponsor-Investigator
Study Sponsor
Richard D. Carvajal
Study Sponsor
Richard D. Carvajal, MD, Principal Investigator, Columbia University
Verification Date
March 2021