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NCT05294289 · ClinicalTrials.gov registry record
Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 77
- Enrollment target
NCT05294289: Completed study, sponsored by Novartis Pharmaceuticals.
NCT05294289 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 77 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05294289 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
Study 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).
Primary Outcome
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 +2 profile. The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Interventions
- OTHER Alpelisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2024-06-28 |
What the finished NCT05294289 record still lists
NCT05294289 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 77 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Alpelisib is the first listed.
NCT05294289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05294289 about?
NCT05294289 is a clinical study titled "Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study". 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).
What is the current status of trial NCT05294289?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2022-05-16. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT05294289?
The interventions under investigation include: Alpelisib (OTHER).
Who is sponsoring clinical trial NCT05294289?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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