An Observational Study in Patients With Unexplained Splenomegaly

Brief Title

A National Study in Patients With Unexplained Splenomegaly

Official Title

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

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
      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
    


Study Type

Observational


Primary Outcome

Percentage of patients diagnosed with Gaucher disease in the included population of patients with unexplained splenomegaly

Secondary Outcome

 Percentage of patients with other than Gaucher disease-etiologies in the included population

Condition

Gaucher Disease



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

506

Start Date

September 2015

Completion Date

April 2021

Primary Completion Date

April 2021

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.
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Sciences & Operations, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04430881

Organization ID

DIREGL07298


Responsible Party

Sponsor

Study Sponsor

Sanofi


Study Sponsor

Clinical Sciences & Operations, Study Director, Sanofi


Verification Date

July 2020