A Non-Interventional National Study in Pediatric Patients With Unexplained Enlarged Spleen
NCT ID: NCT04845958
Last Updated: 2025-09-23
Study Results
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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COMPLETED
60 participants
OBSERVATIONAL
2021-06-30
2024-11-25
Brief Summary
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To assess prevalence of Gaucher disease (GD) diagnosed in pediatric patients presenting with unexplained splenomegaly (SMG) after exclusion of first intention-diagnoses (e.g. portal hypertension, haematological malignancy, hemolytic anemia, infection) based on clinical examination and routine biological tests (full blood count, reticulocytes, liver tests, abdominal ultrasound, Coombs test and Epstein Barr virus serology).
Secondary Objectives:
* To describe the rate of each identified disease category and the rate of patients with no final diagnosis at the end of the study in pediatric patients with unexplained SMG after exclusion of first intention diagnoses
* To describe the characteristics (clinical, lab, genetics) of all pediatric patients included in the study and to describe the characteristics subdivided by identified disease category and absence of final diagnosis at the end of the study
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Pediatric Patients with Unexplained Enlarged Spleen
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient with unexplained SMG (SMG defined as a palpable spleen, already known or discovered for the first time) and who has undergone tests to eliminate obvious causes of SMG
Exclusion Criteria
1. hemolytic anemia
2. hematological malignancy
3. portal hypertension
4. infectious disease associated with SMG (Cytomegalovirus, Epstein Barr virus, leishmaniasis or other obvious infectious cause revealed by the medical history)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
0 Years
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 2500036
Amiens, , France
Investigational Site Number 2500014
Angers, , France
Investigational Site Number 2500034
Argenteuil, , France
Investigational Site Number 2500039
Bayonne, , France
Investigational Site Number 2500015
Besançon, , France
Investigational Site Number 2500003
Bordeaux, , France
Investigational Site Number 2500038
Brest, , France
Investigational Site Number 2500026
Caen, , France
Investigational Site Number 2500018
Chambéry, , France
Investigational Site Number 2500009
Clermont-Ferrand, , France
Investigational Site Number 2500008
Colombes, , France
Investigational Site Number 2500028
Créteil, , France
Investigational Site Number 2500006
Dijon, , France
Investigational Site Number 2500010
Gleizé, , France
Investigational Site Number 2500031
Jossigny, , France
Investigational Site Number 2500040
La Rochelle, , France
Investigational Site Number 2500007
La Tronche, , France
Investigational Site Number 2500030
Limoges, , France
Investigational Site Number 2500001
Lyon, , France
Investigational Site Number 2500032
Mantes-la-Jolie, , France
Investigational Site Number 2500005
Marseille, , France
Investigational Site Number 2500027
Meaux, , France
Investigational Site Number 2500002
Montpellier, , France
Investigational Site Number 2500021
Nantes, , France
Investigational Site Number 2500019
Nice, , France
Investigational Site Number 2500022
Nîmes, , France
Investigational Site Number 2500016
Paris, , France
Investigational Site Number 2500013
Perpignan, , France
Investigational Site Number 2500035
Poissy, , France
Investigational Site Number 2500011
Poitiers, , France
Investigational Site Number 2500029
Reims, , France
Investigational Site Number 2500023
Rennes, , France
Investigational Site Number 2500037
Roubaix, , France
Investigational Site Number 2500024
Rouen, , France
Investigational Site Number 2500017
Saint-Priest-en-Jarez, , France
Investigational Site Number 2500004
Strasbourg, , France
Investigational Site Number 2500033
Toulouse, , France
Investigational Site Number 2500020
Tours, , France
Investigational Site Number 2500025
Valenciennes, , France
Investigational Site Number 2500012
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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U1111-1267-2545
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS16092
Identifier Type: -
Identifier Source: org_study_id
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