Soft Tissue NeoplasmNCT03452644
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
An observational study of Soft Tissue Neoplasm and Soft Tissue Sarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Neoplasm, Soft Tissue Sarcoma, Soft Tissue Mass
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2018to 20 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will enroll 350 patients who underwent US-CNB for soft tissue lesion at the Rizzoli Orthopaedic Institute
Who may be able to join
- Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute
Who cannot join
- Patients whose histological diagnosis is not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Yield of Ultrasound-Guided Needle 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)
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.
- Keywords
- US-CNB, Soft Tissue Mass, Soft Tissue Sarcoma, Soft Tissue Neoplasm, Soft Tissue Lesion
- Medical subject headings
- Soft Tissue Neoplasms, Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start20 Sep 2018
- Primary completion15 Jan 2019
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue NeoplasmStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Bazzocchi, Istituto Ortopedico Rizzoli
- Investigators
- Alberto Bazzocchi, MD, PhD, Principal investigator, The Rizzoli Ortopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452644
- Sponsor's protocol ID
- Softbiopsy@IOReco
- Status last verified
- May 2023
- First submitted
- 23 Feb 2018
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
- ClinicalTrials.gov ID
- NCT03452644
- Acronym / sponsor ID
- Softbiopsy@IOReco
- Keywords
- US-CNB, Soft Tissue Mass, Soft Tissue Sarcoma, Soft Tissue Neoplasm, Soft Tissue Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enroll 350 patients who underwent US-CNB for soft tissue lesion at the Rizzoli Orthopaedic Institute
Key inclusion criteria (1 listed)
- Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute
Key exclusion criteria (1 listed)
- Patients whose histological diagnosis is not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prediction of malignancy
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Bazzocchi, MD, PhD principal investigator
The Rizzoli Ortopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Neoplasm and Soft Tissue Sarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.