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A Prospective Natural History Study in Uveal Melanoma

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ClinicalTrials.gov Identifier: NCT04588662
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Richard D. Carvajal, Columbia University

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.

Condition or disease
Uveal Melanoma

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective Natural History Study in Uveal Melanoma
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


Group/Cohort
Uveal Melanoma
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



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Residual tissue samples from clinical care biopsies that would otherwise be discarded will be collected.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Diagnosis of uveal melanoma
  • Male/Female over the age of 18 years of age
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588662


Contacts
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Contact: Research Nurse Navigator 212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Sulivan, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alex Shoushtari, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marlana Orloff, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sapna Patel, MD         
Sponsors and Collaborators
Richard D. Carvajal
Investigators
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Principal Investigator: Richard D. Carvajal, MD Columbia University
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Responsible Party: Richard D. Carvajal, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT04588662    
Other Study ID Numbers: AAAR5976
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard D. Carvajal, Columbia University:
Uveal Melanoma
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases