Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04588662




Registration number
NCT04588662
Ethics application status
Date submitted
16/07/2020
Date registered
19/10/2020
Date last updated
12/06/2023

Titles & IDs
Public title
A Prospective Natural History Study in Uveal Melanoma
Scientific title
A Prospective Natural History Study in Uveal Melanoma
Secondary ID [1] 0 0
AAAR5976
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveal Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Other cancer types
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relapse-free Survival Rate
Timepoint [1] 0 0
Up to Five years
Primary outcome [2] 0 0
Overall Survival Rate
Timepoint [2] 0 0
Up to Five years
Primary outcome [3] 0 0
Overall Survival Rate of Patients with Uveal Melanoma
Timepoint [3] 0 0
Up to Five years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

*None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Chatswood Eye Specialists - Chatswood
Recruitment hospital [3] 0 0
Royal Victorian Eve and Ear Hospital - East Melbourne
Recruitment hospital [4] 0 0
Western Eye Specialists - Maribyrnong
Recruitment hospital [5] 0 0
Pennington Eye Clinic - North Adelaide
Recruitment hospital [6] 0 0
Perth Retina - Subiaco
Recruitment hospital [7] 0 0
Dr. Conway Private Rooms - Sydney
Recruitment hospital [8] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Chatswood
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Maribyrnong
Recruitment postcode(s) [5] 0 0
- North Adelaide
Recruitment postcode(s) [6] 0 0
- Subiaco
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Toronto
Country [6] 0 0
Germany
State/province [6] 0 0
Erlangen
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Birkenhead
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Northwood
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Columbia University
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04588662
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shaheer Khan, DO
Address 0 0
Columbia University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Research Nurse Navigator
Address 0 0
Country 0 0
Phone 0 0
212-342-5162
Fax 0 0
Email 0 0
cancerclinicaltrials@cumc.columbia.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04588662