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Clinical Trials in Czechia / NCT07609277
Recruiting Observational

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

NCT07609277 · tracked via the Priya Life Science Czechia tracker
Sponsor
St. Anne's University Hospital Brno, Czech Republic
Phase
Observational
Started
2026-01-01
Last updated
2026-05-27

Condition(s) studied

Giant Cell Tumor of BoneTRACP-5bDisease Surveillance and MonitoringTartrate-Resistant Acid Phosphatase 5b

Investigational drug(s) / intervention(s)

Tartrate-Resistant Acid Phosphatase 5b

Tartrate-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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Serum TRACP-5b concentration measured by chemiluminescent immunoassay in patients with active or recurrent giant cell tumor of bone — Up to 24 months.
    Serum TRACP-5b concentration (U/L) measured using a chemiluminescent immunoassay will be evaluated in patients with clinically, radiologically, or histologically confirmed active disease or local recurrence during routine follow-up.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07609277 on ClinicalTrials.gov ↗ ← All trials in Czechia