Mastocytosis Clinical Trial
Official title:
Role of Sclerostin in Mastocytosis Bone Disease
Mastocytosis is very rare and highly heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs and tissues. Bones are the most frequent localization of systemic mastocytosis. The aim of our research was to explain the potential role of sclerostin in the pathogenesis of bone disease in mastocytosis.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2026 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Mastocytosis defined according to WHO criteria - Known KIT mutation status Exclusion Criteria: - History of organ transplant - Inability to give informed consent - Pregnancy, Breastfeeding - Vulnerable Patient, defined as: patient with another uncontrolled severe disease; patient under juridical protection |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Hematooncology and Bone Marrow Transplantation | Lublin | Lubelskie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lublin |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plasma sclerostin measurements (in pmol/l) SOST gene expression by Real-Time PCR dimensions of osteolytic lesions on low-dose computed tomography (in mm) dimensions of osteosclerotic lesions on low-dose computed tomography (in mm) | The Primary Outcome Measures concern:
the measurements of plasma levels of sclerostin and its bioactive form in patients with mastocytosis and healthy volunteers the measurements of levels of sclerostin and its bioactive form in HMC-1.2 human mast cells unstimulated and stimutaled with Il-6 |
1 year | |
Primary | dimensions of osteolytic lesions (in mm) | The Primary Outcome Measures concern:
- the measurements of the dimensions of osteolytic bone lesions on low-dose computed tomography in patients with mastocytosis |
1 year | |
Primary | dimensions of osteosclerotic lesions (in mm) | The Primary Outcome Measures concern:
- the measurements of the dimensions of osteosclerotic bone lesions on low-dose computed tomography in patients with mastocytosis |
1 year |
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