Incisional Biopsy Versus Core-needle Biopsy in Bone Tumor... | NCT07113301

Studies
Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis

NCT07113301

Sponsor

Istituto Ortopedico Rizzoli

Status

Active, not recruiting

Last Update Posted

Aug 8, 2025Actual

Enrollment

42Estimated

Phase

Not provided

Conditions

Malignant Bone Tumor

Interventions

incisional or core-needle biopsy for tumor diagnosis

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2024Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 30, 2025

First Submission Date that Met QC Criteria

Aug 4, 2025

First Posted Date

Aug 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2025

Last Update Posted Date

Aug 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
incisional or core-needle biopsy for tumor diagnosis	Procedure	incisional or core-needle biopsy for tumor diagnosis

Outcomes Module

Primary Outcomes

Measure	Description	Time 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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Irccs Istituto Ortopedico Rizzoli		Bologna	Emilia-Romagna	40134	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20512437	Background	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.
16788939	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques