Epithelioid Hemangioma of Bone And Soft Tissue (EE-META)

May 26, 2017 updated by: Costantino Errani, Istituto Ortopedico Rizzoli

Epithelioid Hemangioma of Bone And Soft Tissue: a Benign Tumor With Metastatic Potential

The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement.

The investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing.

The hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. The purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques.

The hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.

Study Type

Observational

Enrollment (Actual)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with epithelioid hemangioma of bone and soft tissue treated in a single institution

Description

Inclusion Criteria:

  • patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis

Exclusion Criteria:

  • patients with epithelioid hemangioma of bone and soft tissue in the spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multifocal presentation of patients with epithelioid hemangioma of bone and soft tissue without producing a fatal outcome
Time Frame: 2 years
The investigators defined multifocal presentation the presence of secondary lesions by imaging at presentation of the disease or during follow-up.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2015

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

May 17, 2017

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0033566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

publish a manuscript in international journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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