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

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ClinicalTrials.gov Identifier: NCT03452644
Recruitment Status : Unknown
Verified March 2018 by Alberto Bazzocchi, Istituto Ortopedico Rizzoli.
Recruitment status was:  Recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alberto Bazzocchi, Istituto Ortopedico Rizzoli

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

Condition or disease
Soft Tissue Neoplasm Soft Tissue Sarcoma Soft Tissue Mass Soft Tissue Lesion

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients whose histological diagnosis is not available
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452644


Contacts
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Contact: Alberto Bazzocchi, MD, PhD +39 051 636 6836 abazzo@inwind.it
Contact: Daniele Mercatelli, PhD +39 051 6366028 daniele.mercatelli@ior.it

Locations
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Italy
The Rizzoli Orthopaedic Institute Recruiting
Bologna, Bo, Italy, 40136
Contact: Alberto Bazzocchi, MD, PhD    +39 051 636 6836    abazzo@inwind.it   
Contact: Daniele Mercatelli, PhD    + 39 051 6366028 ext Mercatelli    daniele.mercatelli@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Alberto Bazzocchi, MD, PhD The Rizzoli Ortopaedic Institute
More Information
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Responsible Party: Alberto Bazzocchi, Dr., Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03452644    
Other Study ID Numbers: Softbiopsy@IOReco
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alberto Bazzocchi, Istituto Ortopedico Rizzoli:
US-CNB
Soft Tissue Mass
Soft Tissue Sarcoma
Soft Tissue Neoplasm
Soft Tissue Lesion
Additional relevant MeSH terms:
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Sarcoma
Soft Tissue Neoplasms
Neoplasms
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site