Malignant Myoepithelioma of Bone and Soft Tissues: Diagno... | NCT06244420

Studies
Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis

NCT06244420

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Apr 1, 2025Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Myoepithelioma

Interventions

Clinical data review

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2024Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Jan 29, 2024

First Submission Date that Met QC Criteria

Jan 29, 2024

First Posted Date

Feb 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to assess whether there is a correlation between imaging and histology with prognosis in patients with soft tissue and bone MC from the archives of the Rizzoli Orthopaedic Institute all the patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021.	Other: Clinical data review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical data review	Other	review the medical records, radiological imaging, and histological data of these patients	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation	correlation between imaging and histology with prognosis in patients with soft tissue and bone MC.	At baseline (Day 0)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients treated at Rizzoli Orthopaedic Institute between 01 Jan 1998 and 31 Dec 2021
Age ≥ 2 years old
Diagnosis of soft tissue or bone malignant myoepithelioma (MC-SB)
Patients with available clinical and imaging data

Exclusion Criteria:

At least one inclusion criterion not met

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with soft tissue and bone MC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Itituto Ortopedico Rizzoli		Bologna	BO	40136	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33526224	Result	Xu B, Katabi N. Myoepithelial Carcinoma. Surg Pathol Clin. 2021 Mar;14(1):67-73. doi: 10.1016/j.path.2020.09.008. Epub 2021 Jan 5.
25299310	Result	Thway K, Fisher C. Myoepithelial tumor of soft tissue: histology and genetics of an evolving entity. Adv Anat Pathol. 2014 Nov;21(6):411-9. doi: 10.1097/PAP.0000000000000039.

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms