RECRUITING

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

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Conditions

Choroidal MelanomaIndeterminate Lesions of Eye

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.

Official Title

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Quick Facts

Study Start:2019-03-27
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03941379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial.
  2. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Medical Monitor
CONTACT
617-500-8864
clinical@aurabiosciences.com
Medical Monitor
CONTACT

Principal Investigator

Medical Monitor
STUDY_DIRECTOR
Aura Biosciences Inc.

Study Locations (Sites)

Retina Associates SW, P.C.
Tucson, Arizona, 85710
United States
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
United States
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
United States
Retina Consultants of Sacramento
Sacramento, California, 95825
United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, 48073
United States
Retina Center
Minneapolis, Minnesota, 55404
United States
Columbia University Medical Center
New York, New York, 10032
United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239
United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
United States
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
United States
St. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, 37203
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Retina Consultants of Houston
Houston, Texas, 77030
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Aura Biosciences

  • Medical Monitor, STUDY_DIRECTOR, Aura Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-27
Study Completion Date2029-12

Study Record Updates

Study Start Date2019-03-27
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Choroidal Melanoma
  • Indeterminate Lesions of Eye

Additional Relevant MeSH Terms

  • Choroidal Melanoma
  • Indeterminate Lesions of Eye