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GammaGA: Prevalence of Acid Sphingomyelinase Deficiency Disease (ASMD) and Gaucher Disease in Patients With Monoclonal Gammopathies and/or Multiple Myeloma

Recruitingn/aAges 18 Years - 99 YearsAllFundación Española de Hematología y Hemoterapía
NCT05992532 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. 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. Several studies have suggested that there is an increased frequency of MGUS (monoclonal gammopathy of undetermined significance) and/or multiple myeloma (MM) among Gaucher patients. Regarding ASMD (Acid Sph

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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
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What it tests

  • Not listed
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Where

23 sites
Hospital Universitario de Álava
Vitoria-Gasteiz, Spain
Hospital Universitario Torrecárdenas
Almería, Spain
Hospital Son Espases
Palma de Mallorca, Spain
Hospital Parc Taulí
Sabadell, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital de Valdepeñas
Valdepeñas, Spain
Hospital Universitario Dr. Josep Trueta
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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