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Recruiting NCT07421739

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

Conditions: Choroidal Melanoma Indeterminate Lesions Uveal Melanoma Ocular Melanoma

Sponsor: Aura Biosciences

trial.available_in: БГ
Overview
To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
Description
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.
Who can participate
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
Locations 1
Australia (1)
Eye Research Australia
East Melbourne , Victoria
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
12.11.2025
Completion date
15.08.2028
Registry ID
NCT07421739
Source
anzctr
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