NCT05641103Completed
PREDIGA 2: Spanish Acronym of "Educational and Diagnostic Project for Gaucher and ASMD"
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 122 (actual)
- First submitted
- 29 Nov 2022
- Start date
- 21 Mar 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Fundación Española de Hematología y Hemoterapía
- Diseases
- Gaucher disease
- NCT number
- NCT05641103
What you commit to
- Study type: Observational
- Participants enrolled: 122
- From 21 Mar 2023 to the primary completion date, 30 Sept 2024
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Splenomegaly due to portal hypertension (documented by abdominal ultrasound or another instrumental test) caused by liver disease
- Malignant hematologic tumor \[documented by positive physical examination + blood smear or fine-needle aspiration (FNA) or bone marrow biopsy\]
- Patients unable to comply with the protocol requirements due to psychiatric and/or cognitive disorders, non-cooperative patients, or educational and written language comprehension limitations
Other
- Hemolytic anemia and/or thalassemia
- Patient refusal to participate in the study
Who the study is looking for
- Adult patients (over 18 years old) of both sexes.
- Patients presenting signs, assessed instrumentally or via laboratory tests, of:
- Unexplained splenomegaly, defined as a palpable spleen ≥ 1 cm below the costal margin or diagnosed by ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) of the spleen.
- Splenectomized patients without a diagnosis of the cause of unexplained splenomegaly.
- Patients who provide their consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario Universitario La Coruña - CHUAC Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de Poniente Coordinator of this site? Confirm its status | El Ejido | Spain | Unknown status |
| Hospital Universitario de Galdácano Coordinator of this site? Confirm its status | Galdakao | Spain | Unknown status |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Universitario la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Central de Asturias (HUCA) Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| CAU Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Complejo Hospitalario Universitario de Santiago (CHUS) Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitario Joan XXIII Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.