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.
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
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
The study population consists of adult patients with histologically confirmed Giant Cell Tumor of Bone treated or followed at the First Department of Orthopaedic Surgery, St. Anne's University Hospital Brno. The study will include both newly diagnosed patients and patients undergoing long-term surveillance after previous treatment for giant cell tumor of bone. Approximately 70 participants are expected to be enrolled during the study period.
Cohort
Prospective
Tartrate-Resistant Acid Phosphatase 5b
Diagnostic testSerial 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.
Serum TRACP-5b concentration measured by chemiluminescent immunoassay in patients with active or recurrent giant cell tumor of bone
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.
Change in serum TRACP-5b concentration measured by chemiluminescent immunoassay during treatment and follow-up in giant cell tumor of bone
Serial serum TRACP-5b concentrations (U/L), measured using a chemiluminescent immunoassay, will be evaluated over time during routine clinical surveillance, treatment, and follow-up in patients with giant cell tumor of bone.
Correlation between serum TRACP-5b concentration and histopathological findings in giant cell tumor of bone
Correlation between serum TRACP-5b concentration (U/L), measured using a chemiluminescent immunoassay, and histopathological findings obtained from biopsy or surgical specimens when clinically indicated in patients with giant cell tumor of bone.
Serial serum TRACP-5b concentration measurement by chemiluminescent immunoassay during routine clinical follow-up
Evaluation of the feasibility and practical applicability of serial serum TRACP-5b concentration measurements (U/L), performed using a chemiluminescent immunoassay, as a minimally invasive biomarker for long-term surveillance of patients with giant cell tumor of bone.
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St. Anne's University Hospital Brno, Czech Republic
Lead sponsor
Department of Clinical Biochemistry, Institute of Laboratory Medicine of the University Hospital Ostrava
Collaborator
Department of Clinical Biochemistry, St. Anne's University Hospital Brno, Czech Republic
Collaborator
