RecruitingNCT07609277

TRACP-5b for Diagnosis and Follow-up of Giant Cell Tumor of Bone

TRACP-5b as a Novel Biomarker for the Diagnosis and Monitoring of Patients With Giant Cell Tumor of Bone


Sponsor

St. Anne's University Hospital Brno, Czech Republic

Enrollment

70 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This prospective observational study will evaluate whether the blood biomarker TRACP-5b can help diagnose and monitor patients with giant cell tumor of bone (GCTB). GCTB is a rare but locally aggressive bone tumor that can return even after surgical treatment. Currently, patients require long-term follow-up based mainly on imaging examinations such as CT or MRI, and suspected recurrence often requires invasive biopsy procedures. TRACP-5b is an enzyme associated with osteoclast activity that can be measured from a blood sample. Previous studies suggest that TRACP-5b levels may reflect disease activity and risk of recurrence in patients with GCTB. In this study, patients with newly diagnosed GCTB and patients already undergoing long-term follow-up after treatment will undergo regular blood sampling for TRACP-5b measurement during routine outpatient visits. Laboratory results will be compared with the patient's clinical condition, imaging findings, and histological results when available. The goal of the study is to determine whether TRACP-5b could become a reliable and minimally invasive tool for earlier detection of disease recurrence and improved long-term monitoring of patients with giant cell tumor of bone.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Histologically confirmed Giant Cell Tumor of Bone
  • Newly diagnosed patients or patients undergoing long-term follow-up after previous treatment
  • Age ≥18 years
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria4

  • Concurrent diseases significantly affecting bone metabolism, including metabolic bone disorders
  • Inability or unwillingness to provide informed consent
  • Patients unable to comply with routine follow-up procedures
  • Active conditions that may substantially influence serum TRACP-5b levels independently of Giant Cell Tumor of Bone evaluation

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Interventions

DIAGNOSTIC_TESTTartrate-Resistant Acid Phosphatase 5b

Serial measurement of serum TRACP-5b levels in patients with giant cell tumor of bone during routine outpatient follow-up. Peripheral venous blood samples will be collected at scheduled clinical visits and analyzed using a validated immunochemical assay to evaluate the relationship between TRACP-5b levels, disease activity, treatment response, and local recurrence.


Locations(1)

First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia

Brno, Czechia

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NCT07609277


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