Viewing Study NCT06440148



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06440148
Status: RECRUITING
Last Update Posted: 2024-06-03
First Post: 2024-05-06

Brief Title: Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis
Sponsor: Medical University of Lublin
Organization: Medical University of Lublin

Study Overview

Official Title: Role of Sclerostin in Mastocytosis Bone Disease
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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-12 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None