Status:
RECRUITING
GammaGA: Prevalence of Acid Sphingomyelinase Deficiency Disease (ASMD) and Gaucher Disease in Patients With Monoclonal Gammopathies and/or Multiple Myeloma
Lead Sponsor:
Fundación Española de Hematología y Hemoterapía
Conditions:
Gaucher Disease
Acid SphingoMyelinase Deficiency
Eligibility:
All Genders
18-99 years
Brief 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...
Eligibility Criteria
Inclusion
- Adult patients of both sexes.
- Patients with splenomegaly (spleen palpable at ≥ 1cm from the costal margin) or splenectomy not related to any specific condition, or patients with thrombocytopenia (with or without splenomegaly). In cases where the patient is undergoing treatment for their underlying condition, the thrombocytopenia must have been present prior to the start of the treatment.
- Patient who gives their consent to participate in the study.
Exclusion
- 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
Key Trial Info
Start Date :
May 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05992532
Start Date
May 30 2023
End Date
March 1 2026
Last Update
December 9 2025
Active Locations (23)
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1
Hospital Universitario de Álava
Vitoria-Gasteiz, Alava, Spain
2
Hospital Universitario Torrecárdenas
Almería, Almería, Spain
3
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
4
Hospital Parc Taulí
Sabadell, Barcelona, Spain