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Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects

NCT07421739 · Aura Biosciences
In plain English

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About this study
The AU-011-404 study complements the AU-011-301 clinical trial, and aims to identify the broader impact of bel-sar treatment on subjects' daily lives and overall well-being through the collection of PROs. This noninterventional PRO study will provide valuable insights of treatment impact by capturing real-world perspective on aspects including symptom management, functional status, and overall health-related quality of life (QoL). The sites will direct interested participants to the study via a unique URL. Upon accessing the URL, participants will be asked to complete screening questions to confirm their eligibility and review/sign an informed consent document (ICD). Eligible participants will then be asked to complete custom survey questions and the EORTC QLQ-OPT30 questionnaire for up to 24 months.
Eligibility criteria
Inclusion Criteria: * Have enrolled in the Aura-sponsored clinical trial AU-011-301. * Access to a connected device (i.e., smartphone, laptop, or tablet) Exclusion Criteria: * None
Study design
Enrollment target: 15 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2025-11-12
Estimated completion: 2028-08-15
Last updated: 2026-02-19
Interventions
Other: Non-interventional, digital, patient-reported, real-world study
Primary outcomes
  • Change from baseline in EORTC QLQ-C30 scores at month 15 and 24. (24 months)
Sponsor
Aura Biosciences · industry
With: Vitaccess Ltd
Contacts & investigators
ContactMedical Monitor · contact · clinical@aurabiosciences.com · 617-500-8864
InvestigatorStudy Director · study_director, Aura Biosciences
All locations (1)
Eye Research AustraliaRecruiting
East Melbourne, Victoria, Australia