Clinical trial · Observational
Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis
Evaluation of Agreement in Histological Findings Between Core Needle and Incisional Biopsies
- 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)
The investigators will collect data of patients with high suspicion of malignant bone tumor based on radiological imaging who underwent/will undergo both core needle biopsy and incisional biopsy for diagnostic confirmation by histological examination. From 01/01/2015 to the approval date of this study: retrospective study; from the approval date of this study to 31/12/2027: prospective study. the investigators expect to collect data from a total of 72 patients: approximately 30 patients for the retrospective study and 42 for the prospective study. A review will be made from the medical records, radiological imaging, and histological data of partecipants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Bone Tumor | Malignant Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| incisional or core-needle biopsy for tumor diagnosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.
- timeFrame
- through study completion, an average of 3 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 2 years * Patients with high suspicion of malignant bone tumor who underwent/will undergo both core needle biopsy and incisional biopsy * Male and female patients treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027 * Patients with available clinical and imaging data Exclusion Criteria: * Patients with bone tumor who underwent/will undergo only core needle biopsy * Patients with bone tumor who underwent/ will undergo only incisional biopsy
References
Publications (3)
- BACKGROUNDKasraeian S, Allison DC, Ahlmann ER, Fedenko AN, Menendez LR. A comparison of fine-needle aspiration, core biopsy, and surgical biopsy in the diagnosis of extremity soft tissue masses. Clin Orthop Relat Res. 2010 Nov;468(11):2992-3002. doi: 10.1007/s11999-010-1401-x. PMID 20512437
- BACKGROUNDMitsuyoshi G, Naito N, Kawai A, Kunisada T, Yoshida A, Yanai H, Dendo S, Yoshino T, Kanazawa S, Ozaki T. Accurate diagnosis of musculoskeletal lesions by core needle biopsy. J Surg Oncol. 2006 Jul 1;94(1):21-7. doi: 10.1002/jso.20504. PMID 16788939
- BACKGROUNDErrani C, Traina F, Perna F, Calamelli C, Faldini C. Current concepts in the biopsy of musculoskeletal tumors. ScientificWorldJournal. 2013 Jun 5;2013:538152. doi: 10.1155/2013/538152. Print 2013. PMID 23844403