A Prospective Natural History Study in Uveal Melanoma

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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