Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline in EORTC QLQ-C30 scores at month 15 and 24.
研究概览
简要总结
To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have enrolled in the Aura-sponsored clinical trial AU-011-
- •Access to a connected device (i.e., smartphone, laptop, or tablet)
排除标准
- 未提供
研究组 & 干预措施
No Intervention
Observational
干预措施: Non-interventional, digital, patient-reported, real-world study (Other)
结局指标
主要结局
Change from baseline in EORTC QLQ-C30 scores at month 15 and 24.
时间窗: 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.
次要结局
- Change from baseline in EORTC QLQ-OPT30 scores at months 15 and 24.(24 months)