Choroidal Melanoma, Indeterminate Lesions, Ocular Melanoma, Uveal Melanoma
Conditions
Keywords
Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma
Brief summary
To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
Detailed 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.
Interventions
OTHERNon-interventional, digital, patient-reported, real-world study
Surveys will be collected at the following key timepoints: Scheduled visits: Visit 2\_Cycle 1\_Day 1 Visit 8 (week 4, Day 29) Visit 19 (24-hr f/y +/- 4hrs last tx) Visit 20 (week 12, day 84) Visit 22 (week 20, day 84) Visit 25 (week 52, day 364) Visit 26 (week 65, day 455) Visit 27 (week 78, day 546) Visit 28 (week 91, day 637) Visit 29 (week 104, day 728) End of Trial or Early Termination
Sponsors
Aura Biosciences
Vitaccess Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in EORTC QLQ-C30 scores at month 15 and 24. | 24 months | Change from baseline in EORTC QLQ-C30 scores at month 15 and 24 assesses the impact of disease and treatment on cancer patients' quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in EORTC QLQ-OPT30 scores at months 15 and 24. | 24 months | Change from baseline in EORTC QLQ-OPT30 scores at month 15 and 24 assesses the impact of disease and treatment on the quality of life of patients with ophthalmic cancer specifically. |
Countries
Australia
Contacts
CONTACTMedical Monitor
STUDY_DIRECTORStudy Director
Aura Biosciences
Outcome results
None listed