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Evaluation of the Natural History of Patients with Uveal Melanoma
Trial Status: active
This study establishes a registry of patients with uveal melanoma (UM) to study the complete course (natural history) of the disease from diagnosis through initial management, surveillance, and progression. UM is a rare cancer that is distinctly different from the more common melanoma involving the skin (cutaneous). Despite excellent rates of local disease control, up to 50% of patients develop disease that has spread from where it first started (primary site) to other place in the body (metastatic). Advances in therapies for cutaneous melanoma are less effective for UM and have not improved outcomes for patients. Gathering information about patients with UM over time may help researchers learn more about the natural history and progression of the disease and provide data to support the investigation of potential treatments.
Inclusion Criteria
Diagnosis of uveal melanoma
Ability to provide written informed consent for participation in the prospective registry OR an institutional waiver by the institutional review board (IRB)/ethics committee for retrospective data collection without written informed consent
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04588662.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
I. To document clinical outcomes of patients with uveal melanoma, adjusting for known prognostic risk factors as well as other baseline demographic and clinical factors, in order to provide benchmark endpoints for the development of novel therapies for this disease.
SECONDARY OBJECTIVES:
I. To inform critical outstanding questions in the field unlikely to be answered by well-designed prospective clinical trials:
Ia. To document the frequency and type(s) of risk stratification performed for patients with primary uveal melanoma and to prospectively correlate risk stratification methods with relapse-free and overall survival;
Ib. To document the frequency and method(s) of clinical and radiographic surveillance utilized for patients following a diagnosis of primary uveal melanoma, to assess whether there is a correlation between routine radiographic surveillance results and the use of surgical resection or a locally ablative therapy for recurrent disease, and to prospective correlate surveillance methods with relapse-free and overall survival;
Ic. To identify clinical features that may predict clinical benefit from a regional (liver directed) therapy as opposed to systemic therapy;
Id. To document the natural history of uveal melanoma throughout the entirety of the disease course;
Ie. To collect real world data regarding the management of uveal melanoma throughout the entirety of the disease course.
EXPLORATORY OBJECTIVE:
I. To develop a virtual uveal melanoma tumor repository that can be utilized by investigators to develop or confirm hypotheses related to tumor biology and to facilitate drug development.
OUTLINE: This is an observational study.
Patients undergo medical record review on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
