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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).
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 subjects with CM or IL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects previously participated in an Aura Biosciences bel-sar study | Subjects with Choroidal Melanoma or Indeterminate Lesions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Subjects with primary Indeterminate Lesions or Choroidal Melanoma who participated in previous Aura Biosciences sponsored clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Aura Biosciences Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Associates SW, P.C. | Tucson | Arizona | 85710 | United States | ||
| UCLA Jules Stein Eye Institute |
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| Label | URL |
|---|---|
| Ocular Melanoma | View source |
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| 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 |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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