Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis

NCT07113301 | Active Not Recruiting

• 1 other identifier: INSPECTOR
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Malignant Bone Tumor

Outcome Measures

Primary Outcomes (1)

• compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.

  through study completion, an average of 3 year

Interventions

incisional or core-needle biopsy for tumor diagnosis PROCEDURE

incisional or core-needle biopsy for tumor diagnosis

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients surgically treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027

You may qualify if:

• 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

You may not qualify if:

• Patients with bone tumor who underwent/will undergo only core needle biopsy
• Patients with bone tumor who underwent/ will undergo only incisional biopsy

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40134, Italy

Location

Related Publications (3)

• Kasraeian 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 BACKGROUND

• Mitsuyoshi 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 BACKGROUND

• Errani 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 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 8, 2025
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

IT (1)