A Study of the Epidemiology and Hospital Management of Patients With PROS in France
Completed
Conditions studied: PIK3CA-Related Overgrowth Spectrum
In brief
The purpose of this study was to estimate the incidence and prevalence of a group of genetic disorders known as PIK3CA-Related Overgrowth Spectrum (PROS) in France. Additionally, the study aimed to characterize patients, disease management, and costs associated with PROS. This study used data from the French National Hospitals Database, Programme de Médicalisation des Systèmes d'Information (PMSI). The study period was from January 2015 to December 2022.
Key facts
- Study ID
- NCT07222423
- Run by
- Novartis Pharmaceuticals
- People needed
- 3605
- Starts
- 2024-01-15
- Expected to finish
- 2024-10-08
- Last updated by the study team
- 2025-10-29
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Population P1 was identified using a combined query, considering:
- International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes for PROS-related malformations; OR
- PROS-related technical procedures performed during hospitalizations to relieve the symptoms of the disease.
- Subpopulation SP1 was identified through the identification of at least two PROS-related hospitalizations (PROS-related ICD-10-CM or technical procedure code), including the index hospitalization.
You may not qualify if…
- Presence at any time during the entire study period of:
- ICD-10-CM codes for chromosomal malformation; OR
- ICD-10-CM code for hemangioma to avoid inclusion of patients with hemangioma and other vascular malformation; OR
- ICD-10-CM codes associated with the following comorbidities: cancer, cerebrovascular pathologies, hemiplegia (for pediatric patients only), metastatic pathologies, or myocardial infarction.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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