Status:
COMPLETED
A Study of the Epidemiology and Hospital Management of Patients With PROS in France
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
PIK3CA-Related Overgrowth Spectrum
Eligibility:
All Genders
2+ years
Brief Summary
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 ch...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
3605 Patients enrolled
Trial Details
Trial ID
NCT07222423
Start Date
January 15 2024
End Date
October 8 2024
Last Update
October 29 2025
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936