A National Study in Patients With Unexplained Splenomegaly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-04-27

Brief Summary

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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

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Detailed Description

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Study duration per participant is between 1 and 12 months

Conditions

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Gaucher Disease Splenomegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No