A Registry of Patients With Primary Indeterminate Lesions or Choroidal Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 4, 2029
  • participants needed
    500
  • sponsor
    Aura Biosciences
Updated on 4 June 2022

Summary

The purpose of this observational research study is to follow participants who have been treated with either AU-011 or observation and/or received standard of care therapy while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness of AU-011 and standard of care therapy. 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.

Description

This is a multi-center long-term observational Registry of patients with Primary Indeterminate Lesions or Choroidal Melanoma.

The Registry will initially be open to patients who have previously participated in an Aura Biosciences sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.

All patients 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 patients with CM or IL; these patients are routinely followed at 6-month intervals by their treating physician.

Details
Condition Choroidal Melanoma, Indeterminate Lesions of Eye
Clinical Study IdentifierNCT03941379
SponsorAura Biosciences
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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 or assigned to an observation cohort in a previous Aura sponsored clinical trial

Exclusion Criteria

None
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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