Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis

NCT06440148 | Recruiting

• 1 other identifier: SCLERMAST01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastocytosis; Bones

Keywords

Bones; Mastocytosis; Osteolysis; Osteosclerosis; Sclerostin

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

SCLEROSTIN BIOLOGICAL

Pathogenesis of mastocytosis bone disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Age \> 18 years
• Mastocytosis defined according to WHO criteria
• Known KIT mutation status

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Department of Hematooncology and Bone Marrow Transplantation

Lublin, Lublin Voivodeship, 20-081, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The studied material is approximately 2.5 ml of peripheral blood collected into plasma gel tubes. The samples are centrifuged at 3000 rpm for 10 min, plasma is pipetted into tubes.

MeSH Terms

Conditions

Mastocytosis; Osteolysis; Osteosclerosis; Sclerosteosis

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Mast Cell Activation Disorders; Immune System Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Osteochondrodysplasias; Bone Diseases, Developmental

Study Officials

• Aneta A Szudy-Szczyrek, MD., PhD.

  Medical University of Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneta Szudy-Szczyrek, MD., PhD.

CONTACT

+48815345468; aneta.szudy-szczyrek@umlub.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 3, 2024
• Study Start: September 1, 2019
• Primary Completion: May 1, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

PL (1)