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PREDIGA 2: Spanish Acronym of "Educational and Diagnostic Project for Gaucher and ASMD"

NCT05641103 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2026-02-19

No results posted yet for this study

Summary

The study of splenomegaly, and the follow-up of splenectomized patients, is one of the causes of referral of these patients to pediatric gastroenterology and oncohematology clinics, and adult internal medicine and hematology. It has been described that 0.3% of hospital admissions is for this reason.

The study and management of splenomegaly is well described among the different medical specialties to which these patients arrive. After the application of the different algorithms and the different studies that are carried out, these splenomegaly are identified as being of hepatic, infectious, inflammatory, congestive, hematological origin and primary causes. Despite these studies of splenomegaly, approximately 10-15% of these patients still remain undiagnosed.

The objective of the present study is to increase the diagnostic sensitivity of these unknown splenomegalys, or unknown splenomegaly patients who remain in consultations, using the usual diagnostic clinical procedures of unknown splenomegaly and unknown splenectomy patients, where the investigators include the extraction of a blood sample for dry drop test (DBS), where the determination of the enzymatic/genetic activity will be carried out for Gaucher disease (GD) and acid sphingomyelinase deficiency (ASMD) , analysis of LisoGl1 and LisoSM.

Conditions

  • Gaucher Disease
  • Acid SphingoMyelinase Deficiency
  • ASMD
  • Niemann-Pick Diseases
  • Splenomegaly

Interventions

OTHER

Patient with splenomegaly or splenectomy

No interventional study

Sponsors & Collaborators

  • Fundación Española de Hematología y Hemoterapía

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-09-30
Completion
2024-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641103 on ClinicalTrials.gov