Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCLEROSTIN.
- Who it may be relevant to
- Registry conditions: Mastocytosis, Bones. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Sclerostin in Mastocytosis Bone Disease
Overview
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.
Detailed description
Mastocytosis is a heterogeneous group of disorders, characterized by the accumulation of clonal mast cells which can infiltrate several organs, such as the skin, bone marrow or liver. The skeleton is the most frequent localization of systemic mastocytosis (SM). Bone involvement occurs in approximately 70% of SM patients. Pathogenesis of mastocytosis bone disease is poorly understood.
The aim of our research is to explain the potential role of sclerostin, a recently discovered bone tissue protein, in the pathogenesis of bone changes in patients with mastocytosis.
The study group consists of adult patients with mastocytosis divided according to their clinical variants of disease (aggressive systemic mastocytosis - ASM, systemic mastocytosis with an associated hematological neoplasms SM-AHN, smouldering systemic mastocytosis - SSM, indolent systemic mastocytosis - ISM and cutaneous mastocytosis - CM; and group of healthy volunteers.
The concentration of sclerostin, bioactive sclerostin and expression of the SOST gene in human plasma and HMC-1.2 human mast cell culture supernatants is assessed. The Real-Time PCR method is used to evaluate the expression of sclerostin at the mRNA level, while the concentration of the sclerostin protein and its bioactive form is assessed using the enzyme immunoassay ELISA method. The obtained results are correlated with selected demographic, clinical, laboratory and radiological findings. Low-dose CT scan is used to assess bone changes.
These preliminary results could serve that sclerostin may be a new therapeutic target in patients with mastocytosis.
Interventions
- Biological SCLEROSTIN
Pathogenesis of mastocytosis bone disease
Primary outcome measures
- 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) [Time frame: 1 year]
- dimensions of osteolytic lesions (in mm) [Time frame: 1 year]
- dimensions of osteosclerotic lesions (in mm) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Poland · 1 center
- Department of Hematooncology and Bone Marrow Transplantation — Lublin
Identifiers
NCT: NCT06440148 · SCLERMAST01