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OpenTrials
Active, Not Recruiting

NCT Number: NCT07113301

Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Malignant Bone Tumor Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incisional or core-needle biopsy for tumor diagnosis

Procedure

incisional or core-needle biopsy for tumor diagnosis

Primary outcomes

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

    Time frame: through study completion, an average of 3 year

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: INSPECTOR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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