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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05641103
Other study ID # PREDIGA-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 21, 2023
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Fundación Española de Hematología y Hemoterapía
Contact FEHH SEHH
Phone 91 319 19 98
Email sehh@sehh.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date October 15, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients of both sexes. - Patients who present signs, assessed instrumentally or with laboratory tests, of unknown splenomegaly, defined as a palpable spleen = 1cm from the costal margin or diagnosed 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 unknown origin. - 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 Criteria: - Splenomegaly due to portal hypertension (documented by abdominal ultrasound or other instrumental test) due to liver disease - Hematologic malignancy [documented by positive physical exam + blood smear or fine needle aspiration (FNA) or bone marrow biopsy] - Hemolytic anemia and/or thalassemia - Patients who cannot meet the requirements of the protocol due to mental and/or cognitive alterations, uncooperative patients, educational limitations and understanding of written language - Refusal of the patient to participate in the study

Study Design


Intervention

Other:
Patient with splenomegaly or splenectomy
No interventional study

Locations

Country Name City State
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Universitario de Badajoz Badajoz
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital de Poniente El Ejido Almería
Spain Hospital Universitario de Galdácano Galdácano Vizcaya
Spain Hospital Universitario de Cabueñes Gijón Asturias
Spain Hospital Universitario Juan Ramón Jiménez Huelva
Spain Complejo Hospitalario Universitario La Coruña - CHUAC La Coruña
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital Universitario La Princesa Madrid
Spain Hospital Universitario Central de Asturias - HUCA Oviedo Asturias
Spain Hospital Universitario de Navarra Pamplona Navarra
Spain CAU Salamanca Salamanca
Spain Complejo Hospitalario Universitario de Santiago - CHUS Santiago De Compostela La Coruña
Spain Hospital Nuestra Señora del Prado Talavera De La Reina Toledo
Spain Hospital Universitario Joan XXIII Tarragona

Sponsors (1)

Lead Sponsor Collaborator
Fundación Española de Hematología y Hemoterapía

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Gaucher disease (GD) and acid sphingomyelinase deficiency (ASMD) Determinate the prevalence of Gaucher disease (GD) and acid sphingomyelinase deficiency (ASMD) 36 months
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