NCT04430881

A National Study in Patients With Unexplained Splenomegaly

The SMS Study, a National Study on Prevalence of Unexplained Splenomegaly Etiologies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 506 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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 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

Detailed description

Study duration per participant is between 1 and 12 months

Conditions

• Gaucher Disease
• Splenomegaly

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2020-06-12
• Last updated: 2022-04-25

Locations

1 site across 1 country: France