Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Lublin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years
Mastocytosis defined according to WHO criteria
Known KIT mutation status
Disqualifiers
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
Trial population
The study group consists of adult patients diagnosed with mastocytosis, divides according to the clinical variants: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), indolent systemic mastocytosis (ISM), smoldering systemic mastocytosis (SSM) and cutaneous mastocytosis (CM). The diagnosis of mastocytosis should be established based on biopsy of the affected organ (bone marrow trephine biopsy, skin affected by the disease), following the 2022 WHO classification. The control group comprised 30 healthy volunteers matched with the study group in terms of age and gender.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
SCLEROSTIN
Biological/VaccinePathogenesis of mastocytosis bone disease
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
1 year2
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
Time frame
1 year3
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
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov