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

Last updated: February 17, 2025
Sponsor: Fundación Española de Hematología y Hemoterapía
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Gaucher Disease

Treatment

Patient with splenomegaly or splenectomy

Clinical Study ID

NCT05641103
PREDIGA-2
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients of both sexes.

  • Patients who present signs, assessed instrumentally or with laboratory tests, ofunknown splenomegaly, defined as a palpable spleen ≥ 1cm from the costal margin ordiagnosed by ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) of the spleen.

  • Splenectomy patient with no diagnosis of the origin of the splenomegaly of unknownorigin.

  • Patients with splenomegaly or splenectomy without diagnosis but identified with ITP (Idiopathic Thrombocytopenic Purpura)

  • Patient who gives his consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Splenomegaly due to portal hypertension (documented by abdominal ultrasound or otherinstrumental test) due to liver disease

  • Hematologic malignancy [documented by positive physical exam + blood smear or fineneedle aspiration (FNA) or bone marrow biopsy]

  • Hemolytic anemia and/or thalassemia

  • Patients who cannot meet the requirements of the protocol due to mental and/orcognitive alterations, uncooperative patients, educational limitations andunderstanding of written language

  • Refusal of the patient to participate in the study

Study Design

Total Participants: 122
Treatment Group(s): 1
Primary Treatment: Patient with splenomegaly or splenectomy
Phase:
Study Start date:
March 21, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hospital de Poniente

    El Ejido, Almería
    Spain

    Site Not Available

  • Hospital Universitario de Cabueñes

    Gijón, Asturias
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias - HUCA

    Oviedo, Asturias
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago - CHUS

    Santiago De Compostela, La Coruña
    Spain

    Site Not Available

  • Hospital Universitario de Navarra

    Pamplona, Navarra
    Spain

    Site Not Available

  • Hospital Nuestra Señora del Prado

    Talavera De La Reina, Toledo
    Spain

    Site Not Available

  • Hospital Universitario de Galdácano

    Galdácano, Vizcaya
    Spain

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante,
    Spain

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz,
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramón Jiménez

    Huelva,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario La Coruña - CHUAC

    La Coruña,
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo,
    Spain

    Site Not Available

  • Hospital Universitario La Princesa

    Madrid,
    Spain

    Site Not Available

  • CAU Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Hospital Universitario Joan XXIII

    Tarragona,
    Spain

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.