Clinical trial NCT04588662: A Prospective Natural History Study in Uveal Melanoma
Official title: A Prospective Natural History Study in Uveal Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveal Melanoma
Keywords: Uveal Melanoma
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Diagnosis of uveal melanoma
* Male/Female over the age of 18 years of age

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.

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

Primary outcomes:
measure: Relapse-free Survival Rate
timeFrame: Up to Five years
measure: Overall Survival Rate
timeFrame: Up to Five years
measure: Overall Survival Rate of Patients with Uveal Melanoma
timeFrame: Up to Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Chatswood
country: Australia
facility: Chatswood Eye Specialists
city: East Melbourne
country: Australia
facility: Royal Victorian Eve and Ear Hospital
city: Maribyrnong
country: Australia
facility: Western Eye Specialists
city: North Adelaide
country: Australia
facility: Pennington Eye Clinic
city: Subiaco
country: Australia
facility: Perth Retina
city: Sydney
country: Australia
facility: Dr. Conway Private Rooms
city: Sydney
country: Australia
facility: St. Vincent's Hospital
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
city: Erlangen
country: Germany
facility: Erlangen
city: Birkenhead
country: United Kingdom
facility: Clatterbridge Cancer Centre
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Sheffield
country: United Kingdom
facility: Sheffield
Study officials:
affiliation: Columbia University
name: Shaheer Khan, DO
role: PRINCIPAL_INVESTIGATOR
References: