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Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Completed
CT.gov ID
NCT03759327
Collaborator
(none)
9
Enrollment
1
Location
5.8
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

single institution cases series review of histological and clinical data

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    single institution cases series review of histological and clinical data Investigators will retrieve from the archives of the Rizzoli Institute all the cases with a histological diagnosis of Angiomatoid Fibrous Histiocytoma. In all cases with enough available material, immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue tumor material.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series
    Actual Study Start Date :
    Nov 30, 2018
    Actual Primary Completion Date :
    May 1, 2019
    Actual Study Completion Date :
    May 25, 2019

    Outcome Measures

    Primary Outcome Measures

    1. selection and review of 9 cases of Angiomatoid Fibrous Histiocytoma [at baseline (Day0)]

      investigators will review all the medical records, radiological imaging, and histological slides of all cases to identify the best therapeutic approach.

    2. analysis of EWS-CREB1 and EWS-ATF1 mutation and ALK expression on tissue tumor material [at baseline (Day0)]

      In all cases immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue tumor material. EWS-CREB1 and EWS-ATF1 mutation and ALK expression will be analyzed with RT-PCR and/or FISH analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Male and female patients treated at Rizzoli Institute from 01 January 2006 to 31 December 2017

    • Diagnosis of Angiomatoid Fibrous Histiocytoma

    • Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis

    • Written informed consent prior to any study-specific analysis and/or data collection

    Exclusion Criteria:

    • Patients with histological diagnosis different from Angiomatoid Fibrous Histiocytoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCC Rizzoli Orthopedic Institute Bologna Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT03759327
    Other Study ID Numbers:
    • AFH
    First Posted:
    Nov 30, 2018
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Histiocytoma
    Histiocytoma, Benign Fibrous
    Histiocytoma, Malignant Fibrous

    Study Results

    No Results Posted as of Feb 13, 2020