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Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis

Evaluation of Agreement in Histological Findings Between Core Needle and Incisional Biopsies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07113301
Acronym
INSPECTOR
Enrollment
42
Registered
2025-08-08
Start date
2024-11-05
Completion date
2027-12-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Bone Tumor

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.

Interventions

PROCEDUREincisional or core-needle biopsy for tumor diagnosis

incisional or core-needle biopsy for tumor diagnosis

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.through study completion, an average of 3 year

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026