A National Study in Patients With Unexplained Splenomegaly (SMS)

Sanofi

Status: Completed

Conditions: Splenomegaly; Gaucher Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04430881

DIREGL07298

Details and patient eligibility

About

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

Full description

Study duration per participant is between 1 and 12 months

Enrollment: 506 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.