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A National Study in Patients With Unexplained Splenomegaly

CompletedN/A

Sponsor: Sanofi

Conditions: Gaucher Disease, Splenomegaly

Countries: France

Primary Objective: To estimate the prevalence of Gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams (e.g. full blood count, liver enzymes, reticulocytes) Secondary Objective: To describe the exams and tests conducted for diagnosis purpose and the more frequent associations

Eligibility overview

Sex: ALL

Age: 15 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion criteria:

* Participants referred for the first time for splenomegaly exploration defined as :

  * Either a palpable mass on left upper abdominal quadrant, further confirmed by a ≥ 13 cm craniocaudal length on abdominal Imaging
  * Or a non palpable splenomegaly discovered on abdominal imaging and with a craniocaudal length ≥ 13 cm
* Participants with splenomegaly (as defined above) of unknown origin

Exclusion criteria:

* Participants with obvious diagnostics based on clinical exam, patient's interview and the previous initial routine biological tests :

  * Diagnosis of portal hypertension
  * Diagnosis of hemolytic anemia
  * Diagnosis of hematological malignancy
  * Known diagnosis of Gaucher Disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

France, France