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JOURNAL ONKOLOGIE – STUDIE

A Prospective Natural History Study in Uveal Melanoma

Rekrutierend

NCT-Nummer:
NCT04588662

Studienbeginn:
Mai 2021

Letztes Update:
12.06.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Melanoma, Uveal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Columbia University

Collaborator:
-

Studienleiter

Shaheer Khan, DO
Principal Investigator
Columbia University

Kontakt

Studienlocations
(3 von 17)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Relapse-free Survival Rate (Time Frame - Up to Five years):
Document the relapse-free survival of patients with uveal melanoma from the time of diagnosis of primary disease

2. Overall Survival Rate (Time Frame - Up to Five years):
document the overall survival of patients with uveal melanoma from the time of diagnosis of primary disease

3. Overall Survival Rate of Patients with Uveal Melanoma (Time Frame - Up to Five years):
document the overall survival of patients with uveal melanoma from the time of development of metastatic disease

Quelle: ClinicalTrials.gov


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