Uveal Melanoma Clinical Trial
Official title:
A Prospective Natural History Study in Uveal Melanoma
NCT number | NCT04588662 |
Other study ID # | AAAR5976 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 6, 2021 |
Est. completion date | July 2026 |
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | July 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Australia | Chatswood Eye Specialists | Chatswood | |
Australia | Royal Victorian Eve and Ear Hospital | East Melbourne | |
Australia | Western Eye Specialists | Maribyrnong | |
Australia | Pennington Eye Clinic | North Adelaide | |
Australia | Perth Retina | Subiaco | |
Australia | Dr. Conway Private Rooms | Sydney | |
Australia | St. Vincent's Hospital | Sydney | |
Canada | Princess Margaret Cancer Center | Toronto | |
Germany | Erlangen | Erlangen | |
United Kingdom | Clatterbridge Cancer Centre | Birkenhead | |
United Kingdom | Mount Vernon Cancer Centre | Northwood | |
United Kingdom | Sheffield | Sheffield | |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States, Australia, Canada, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse-free Survival Rate | Document the relapse-free survival of patients with uveal melanoma from the time of diagnosis of primary disease | Up to Five years | |
Primary | Overall Survival Rate | document the overall survival of patients with uveal melanoma from the time of diagnosis of primary disease | Up to Five years | |
Primary | Overall Survival Rate of Patients with Uveal Melanoma | document the overall survival of patients with uveal melanoma from the time of development of metastatic disease | Up to Five years |
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