Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease Surveillance and Monitoring | — | UNRESOLVED | — |
| Giant Cell Tumor of Bone | Giant Cell Tumor of Bone | ONTOLOGY_EXACT | 0.98 |
| Tartrate-Resistant Acid Phosphatase 5b | — | UNRESOLVED | — |
| TRACP-5b | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tartrate-Resistant Acid Phosphatase 5b | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Serum TRACP-5b concentration measured by chemiluminescent immunoassay in patients with active or recurrent giant cell tumor of bone
- timeFrame
- Up to 24 months.
- description
- 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.
Secondary outcomes (3)
- measure
- Change in serum TRACP-5b concentration measured by chemiluminescent immunoassay during treatment and follow-up in giant cell tumor of bone
- timeFrame
- Up to 24 months.
- description
- 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.
- measure
- Correlation between serum TRACP-5b concentration and histopathological findings in giant cell tumor of bone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available