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NCT03452644 Clinical Trial

US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Soft Tissue Sarcoma Clinical Trial

Official title:
Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03452644
Other study ID # Softbiopsy@IOReco
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2018
Est. completion date September 20, 2020

Study information
Verified date May 2023
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)

Description:

The present study is designed to be the first step in the creation of an interdisciplinary platform collecting data on patients and procedures to provide a predictive tool to help physicians in the management of patients affected by a soft tissue lesion. The primary aim of our work is to evaluate the diagnostic yield of US-CNB. The secondary aim is to exploit all the imaging data conventionally available at a Sarcoma Center before a biopsy on a soft tissue mass, to build a multiparametric model and score of prediction of malignancy, and eventually of biological behavior - grading.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date September 20, 2020
Est. primary completion date January 15, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute Exclusion Criteria: - Patients whose histological diagnosis is not available

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy The Rizzoli Orthopaedic Institute Bologna Bo

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic yield Diagnostic yield will be defined as the number of diagnostic core needle biopsies divided by the total number of core needle biopsies. A diagnostic yield > 94% will be considered sufficient to produce a sample to reach the histological diagnosis. One year
Secondary Prediction of malignancy To determine which imaging features and biomarkers correlates with malignancy and biological behavior of soft tissue masses. One year
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