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

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ClinicalTrials.gov Identifier: NCT03169595
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Costantino Errani, Istituto Ortopedico Rizzoli

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Epithelioid Hemangioma of Bone Epithelioid Hemangioma Procedure: Surgery

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 Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Epithelioid Hemangioma of Bone And Soft Tissue: a Benign Tumor With Metastatic Potential
Actual Study Start Date : October 7, 2015
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : May 17, 2017

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MedlinePlus related topics: Birthmarks

Groups and Cohorts
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Intervention Details:
  • Procedure: Surgery
    Patients affected by epithelioid hemangioma treated with surgery

Outcome Measures
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Primary Outcome Measures :
  1. 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.


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:   Probability Sample
Study Population
Patients with epithelioid hemangioma of bone and soft tissue treated in a single institution
Criteria

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
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): NCT03169595


Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Director: Davide Donati, MD Istituto Ortopedico Rizzoli
More Information
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Responsible Party: Costantino Errani, MD, PhD., Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03169595    
Other Study ID Numbers: 0033566
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publish a manuscript in international journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Angiolymphoid Hyperplasia with Eosinophilia
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Eosinophilia
 Leukocyte Disorders
Hematologic Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Skin Diseases