A Prospective Natural History Study in Uveal Melanoma

Last updated: July 10, 2024
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Treatment

N/A

Clinical Study ID

NCT04588662
AAAR5976
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 700
Study Start date:
May 06, 2021
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Active - Recruiting

  • Chatswood Eye Specialists

    Chatswood,
    Australia

    Active - Recruiting

  • Royal Victorian Eve and Ear Hospital

    East Melbourne,
    Australia

    Site Not Available

  • Western Eye Specialists

    Maribyrnong,
    Australia

    Active - Recruiting

  • Pennington Eye Clinic

    North Adelaide,
    Australia

    Active - Recruiting

  • Perth Retina

    Subiaco,
    Australia

    Active - Recruiting

  • Dr. Conway Private Rooms

    Sydney,
    Australia

    Active - Recruiting

  • St. Vincent's Hospital

    Sydney,
    Australia

    Active - Recruiting

  • Pricness Margaret Cancer Center

    Toronto,
    Canada

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto,
    Canada

    Active - Recruiting

  • Erlangen

    Erlangen,
    Germany

    Site Not Available

  • Clatterbridge Cancer Centre

    Birkenhead,
    United Kingdom

    Active - Recruiting

  • Mount Vernon Cancer Centre

    Northwood,
    United Kingdom

    Site Not Available

  • Sheffield

    Sheffield,
    United Kingdom

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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