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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04588662
Registration number
NCT04588662
Ethics application status
Date submitted
16/07/2020
Date registered
19/10/2020
Titles & IDs
Public title
A Prospective Natural History Study in Uveal Melanoma
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Scientific title
A Prospective Natural History Study in Uveal Melanoma
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Secondary ID [1]
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AAAR5976
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uveal Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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Other cancer types
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Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Relapse-free Survival Rate
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Assessment method [1]
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Document the relapse-free survival of patients with uveal melanoma from the time of diagnosis of primary disease
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Timepoint [1]
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Up to Five years
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Primary outcome [2]
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Overall Survival Rate
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Assessment method [2]
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document the overall survival of patients with uveal melanoma from the time of diagnosis of primary disease
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Timepoint [2]
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Up to Five years
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Primary outcome [3]
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Overall Survival Rate of Patients with Uveal Melanoma
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Assessment method [3]
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document the overall survival of patients with uveal melanoma from the time of development of metastatic disease
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Timepoint [3]
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Up to Five years
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
*None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Chatswood Eye Specialists - Chatswood
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Recruitment hospital [3]
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Royal Victorian Eve and Ear Hospital - East Melbourne
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Recruitment hospital [4]
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Western Eye Specialists - Maribyrnong
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Recruitment hospital [5]
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Pennington Eye Clinic - North Adelaide
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Recruitment hospital [6]
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Perth Retina - Subiaco
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Recruitment hospital [7]
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Dr. Conway Private Rooms - Sydney
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Recruitment hospital [8]
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St. Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Chatswood
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Recruitment postcode(s) [3]
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- East Melbourne
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Recruitment postcode(s) [4]
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- Maribyrnong
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Recruitment postcode(s) [5]
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- North Adelaide
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Recruitment postcode(s) [6]
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- Subiaco
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Recruitment postcode(s) [7]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Canada
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State/province [5]
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Toronto
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Country [6]
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Germany
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State/province [6]
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Erlangen
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Country [7]
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United Kingdom
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State/province [7]
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Birkenhead
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Country [8]
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United Kingdom
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State/province [8]
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Northwood
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Country [9]
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United Kingdom
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State/province [9]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Other
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Name
Columbia University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04588662
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Shaheer Khan, DO
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Address
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Columbia University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Research Nurse Navigator
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Address
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Country
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Phone
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212-342-5162
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04588662