A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
NCT ID: NCT03941379
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2019-03-27
2029-12-31
Brief Summary
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Detailed Description
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The Registry will initially be open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.
All subjects will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first.
No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for subjects with CM or IL.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Subjects previously participated in an Aura Biosciences bel-sar study
Subjects with Choroidal Melanoma or Indeterminate Lesions.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Have received AU-011 bel-sar or assigned to a different cohort or treatment arm (sham, SoC, etc.) an observation cohort in a previous Aura sponsored clinical trial.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aura Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Aura Biosciences Inc.
Locations
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Retina Associates SW, P.C.
Tucson, Arizona, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Retina Consultants of Sacramento
Sacramento, California, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, United States
Retina Center
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina, PA
Greenville, South Carolina, United States
St. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Medical Monitor
Role: CONTACT
Facility Contacts
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Amy Merz
Role: primary
Rosaleen Ostrick
Role: primary
Mariana Nunez
Role: primary
Grayson Hanlon
Role: primary
Pamela Campbell
Role: primary
Kendra Mellert
Role: primary
Andi Gilchrist, BS CMSS
Role: primary
Ellen Alt
Role: primary
Ann Lundquist
Role: primary
Lisa Flynn
Role: primary
Lauren Frazier
Role: primary
Lisa Walden
Role: primary
Sally Arceneaux
Role: primary
Allison Stroh
Role: primary
Bonnie Verges
Role: primary
Related Links
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Ocular Melanoma
Other Identifiers
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Registry AU-011-401
Identifier Type: -
Identifier Source: org_study_id