A Study of the Epidemiology and Hospital Management of Patients With PROS in France

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-10-08

Brief Summary

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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.

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Detailed Description

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Conditions

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PIK3CA-Related Overgrowth Spectrum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Target Population (P1)

Children and adults hospitalized for disease management of PROS.

No interventions assigned to this group

Subpopulation (SP1)

Patients from P1 with at least two PROS-related hospitalizations (including the index hospitalization).

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No