NCT03452644

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

February 23, 2018

Last Update Submit

May 22, 2023

Conditions

Soft Tissue NeoplasmSoft Tissue SarcomaSoft Tissue MassSoft Tissue Lesion

Keywords

US-CNBSoft Tissue MassSoft Tissue SarcomaSoft Tissue NeoplasmSoft Tissue Lesion

Outcome Measures

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.

    One year

Secondary Outcomes (1)

  • Prediction of malignancy

    One year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients whose histological diagnosis is not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rizzoli Orthopaedic Institute

Bologna, Bo, 40136, Italy

Location

MeSH Terms

Conditions

Soft Tissue NeoplasmsSarcoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Alberto Bazzocchi, MD, PhD

    The Rizzoli Ortopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 2, 2018

Study Start

September 20, 2018

Primary Completion

January 15, 2019

Study Completion

September 20, 2020

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)