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A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Trial Status: closed to accrual
The purpose of this observational research study is to follow participants who have been
treated with bel-sar while participating in a previous Aura Biosciences clinical research
study to assess the long-term safety and effectiveness in these subjects. The study will
collect information based on assessments performed as part of the standard of care (SoC)
for subjects with IL/CM, inclusive of all adverse events, concomitant medications and/or
procedures, information regarding metastatic disease and details of treatments
administered, and information about melanoma-related and all-cause mortality and cause of
death (if applicable).
Inclusion Criteria
Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial.
Have received AU-011 bel-sar treatment in a previous Aura Biosciences sponsored clinical trial.
Have completed the exit visit of the previous Aura Biosciences sponsored clinical trial within 1 year of Day 1 (≤365 days) of enrollment into the Registry.
Exclusion Criteria
None
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03941379.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Status: Active
Contact: Michael M Altaweel
Phone: 608-263-7171
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not Available
This is a multi-center long-term observational Registry of subjects with Primary
Indeterminate Lesions or Choroidal Melanoma.
The Registry is 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
