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Completed

NCT Number: NCT03452644

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

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

Completed

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Key information

Conditions

Soft Tissue Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma Soft Tissue Lesion Soft Tissue Mass Soft Tissue Neoplasms Soft Tissue Sarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

The Rizzoli Orthopaedic Institute

Bologna, Bo, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute

Exclusion criteria

  • Patients whose histological diagnosis is not available

Treatment and study plan

Primary outcomes

  1. Diagnostic yield

    Time frame: One year

    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.

Secondary outcomes

  1. Prediction of malignancy

    Time frame: One year

    To determine which imaging features and biomarkers correlates with malignancy and biological behavior of soft tissue masses.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 2, 2018
Registry last updated
May 23, 2023

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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