NCT07609277 TRACP-5b for Diagnosis and Follow-up of Giant Cell Tumor of Bone
| NCT ID | NCT07609277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Anne's University Hospital Brno, Czech Republic |
| Condition | Giant Cell Tumor of Bone |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Vasileios Apostolopoulos, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Frequently Asked Questions
Who can join the NCT07609277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Giant Cell Tumor of Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07609277 currently recruiting?
Yes, NCT07609277 is actively recruiting participants. Contact the research team at vasileios.apostolopoulos@fnusa.cz for enrollment information.
Where is the NCT07609277 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT07609277 clinical trial?
NCT07609277 is sponsored by St. Anne's University Hospital Brno, Czech Republic. The principal investigator is Vasileios Apostolopoulos, M.D., Ph.D. at First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia. The trial plans to enroll 70 participants.