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| Name | Class |
|---|---|
| Vitaccess Ltd | INDUSTRY |
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To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention | Observational |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional, digital, patient-reported, real-world study | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in EORTC QLQ-C30 scores at month 15 and 24. | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in EORTC QLQ-OPT30 scores at months 15 and 24. | 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participating in Aura's Phase 3 CoMpass trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Contact | 617-500-8864 | clinical@aurabiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Aura Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Australia | Recruiting | East Melbourne | Victoria | 3002 | Australia |
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| Label | URL |
|---|---|
| Aura Biosciences | View source |
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|
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D005134 | Eye Neoplasms |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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