Clinical trial · Observational
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
NCT07421739CI-TRIAL-00103665recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choroidal Melanoma | Choroid Melanoma | ALIAS | 0.90 |
| Indeterminate Lesions | — | UNRESOLVED | — |
| Ocular Melanoma | Ocular Melanoma | ONTOLOGY_EXACT | 0.98 |
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-interventional, digital, patient-reported, real-world study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- No Intervention
- description
- Observational
- interventionNames
- Other: Non-interventional, digital, patient-reported, real-world study
Primary outcomes (1)
- measure
- Change from baseline in EORTC QLQ-C30 scores at month 15 and 24.
- timeFrame
- 24 months
- description
- 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 outcomes (1)
- measure
- Change from baseline in EORTC QLQ-OPT30 scores at months 15 and 24.
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.