Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects

ConditionsChoroidal Melanoma Indeterminate Lesions Uveal Melanoma Ocular Melanoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorAura Biosciences

About this trial

To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have enrolled in the Aura-sponsored clinical trial AU-011-301.

Access to a connected device (i.e., smartphone, laptop, or tablet)

Disqualifiers

None

Trial population

Participating in Aura's Phase 3 CoMpass trial.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Non-interventional, digital, patient-reported, real-world study
Other intervention
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

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: No Intervention1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

24 months

Secondary outcomes

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.

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aura Biosciences

Lead sponsor

Vitaccess Ltd

Collaborator

Source ClinicalTrials.gov

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