Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis

NCT ID: NCT07113301

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-05

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Bone Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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incisional or core-needle biopsy for tumor diagnosis

incisional or core-needle biopsy for tumor diagnosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Irccs Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 20512437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16788939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23844403 (View on PubMed)

Other Identifiers

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INSPECTOR

Identifier Type: -

Identifier Source: org_study_id

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