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CompletedNCT03452644Updated May 23, 2023

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

An observational study in Soft Tissue Neoplasm, Soft Tissue Sarcoma and Soft Tissue Mass, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
350
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Soft Tissue Neoplasm
  • Soft Tissue Sarcoma
  • Soft Tissue Mass
  • Soft Tissue Lesion

Keywords

  • US-CNB
  • Soft Tissue Mass
  • Soft Tissue Sarcoma
  • Soft Tissue Neoplasm
  • Soft Tissue Lesion
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will enroll 350 patients who underwent US-CNB for soft tissue lesion at the Rizzoli Orthopaedic Institute

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients whose histological diagnosis is not available
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
350 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

Secondary outcomes

  1. Prediction of malignancy

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

    Time frame: One year

06

Study locations

1 site
  • The Rizzoli Orthopaedic Institute
    Bologna, Bo 40136, Italy
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03452644
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Alberto Bazzocchi (Dr., Istituto Ortopedico Rizzoli) — Principal investigator
First posted
Mar 2, 2018
Start date
Sep 20, 2018
Primary completion
Jan 15, 2019
Completion
Sep 20, 2020
Last update
May 23, 2023

Study contacts

Alberto Bazzocchi, MD, PhD
principal investigator · The Rizzoli Ortopaedic Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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