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PI3K Inhibitor
Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study
East Hanover, NJ
N/A
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
This is a mixed-methods observational study that incorporates both qualitative interviews and quantitative data collection through a web-based longitudinal survey (day 1, months 2 and 4).
See full description
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brief Pain Inventory for Adult Self-Report and Adolescent Self-Report
EQ-5D-5L for Adult self-report
EQ-5D-Youth for adolescent Self-Report and Caregiver-Proxy
+5 moreSecondary study objectives
Description of change in HRQoL, symptom severity, and pain as a result of treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: PROS patients treated with alpelisibExperimental Treatment1 Intervention
Patients with PROS who receive treatment with alpelisb
Group II: PROS patients not treated with alpelisibExperimental Treatment0 Interventions
Patients with PROS who don't receive treatment with apelisib
Find a Location
Closest Location:Novartis Investigative Site· East Hanover, NJ· 459 miles
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,960 Previous Clinical Trials
4,274,614 Total Patients Enrolled