Status:
COMPLETED
A National Study in Patients With Unexplained Splenomegaly
Lead Sponsor:
Sanofi
Conditions:
Gaucher Disease
Splenomegaly
Eligibility:
All Genders
15+ years
Brief Summary
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 intenti...
Detailed Description
Study duration per participant is between 1 and 12 months
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT04430881
Start Date
September 1 2015
End Date
April 27 2021
Last Update
April 25 2022
Active Locations (1)
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1
Investigational site France
France, France