Patient-reported quality of life after bel-sar treatment in AU-011-301 participants
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
See how bel-sar treatment affects daily life and quality of life for people with choroidal/uveal melanoma who are enrolled in AU-011-301 by collecting online patient questionnaires.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Aura Biosciences Industry-sponsored |
| Locations | 1 site (East Melbourne, Victoria) |
| Trial ID | NCT07421739 on ClinicalTrials.gov |
What this trial studies
This non-interventional, digital patient-reported outcomes (PRO) study asks participants from the global AU-011-301 trial to complete custom survey questions and the validated EORTC QLQ-OPT30 questionnaire up to 24 months. Sites will invite interested AU-011-301 participants via a unique URL where they complete screening questions and e-consent before starting surveys. The study captures real-world information on symptoms, functional status, symptom management, and overall health-related quality of life without changing clinical care. Data are collected remotely on connected devices to understand the broader daily-life impact of bel-sar treatment.
Who should consider this trial
Good fit: Ideal candidates are people already enrolled in the Aura-sponsored AU-011-301 trial who can access a smartphone, tablet, or computer and are willing to complete online questionnaires.
Not a fit: Patients not enrolled in AU-011-301 or those without reliable access to a connected device are not eligible and will not receive information or direct clinical benefit from this observational PRO study.
Why it matters
Potential benefit: If successful, the study could clarify how bel-sar affects patients' day-to-day functioning and well-being, helping clinicians and researchers improve supportive care and future trial design.
How similar studies have performed: Collecting PROs with validated EORTC questionnaires is an established method in cancer research, but PRO data specific to bel-sar in AU-011-301 participants remain novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
East Melbourne, Victoria
- Eye Research Australia — East Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Medical Monitor
- Email: clinical@aurabiosciences.com
- Phone: 617-500-8864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.