Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study
NCT05294289 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77
Last updated 2025-06-24
Summary
This was a mixed-methods observational study that incorporated both qualitative interviews and longitudinal quantitative data collection through an online survey (initial, 2 months, and 4 months).
Conditions
- PIK3CA-related Overgrowth Spectrum
Interventions
- OTHER
-
Alpelisib
There was no treatment allocation. Patients administered alpelisib by prescription that were involved in Novartis' alpelisib managed access program were enrolled
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 5 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-16
- Primary Completion
- 2024-06-28
- Completion
- 2024-06-28
Countries
- United States
Study Locations
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