Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series

February 11, 2020 updated by: Istituto Ortopedico Rizzoli
single institution cases series review of histological and clinical data

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCC Rizzoli Orthopedic Institute

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and Female with diagnosis of Angiomatoid Fibrous Histiocytoma with histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis

Description

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

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: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
selection and review of 9 cases of Angiomatoid Fibrous Histiocytoma
Time Frame: at baseline (Day0)
investigators will review all the medical records, radiological imaging, and histological slides of all cases to identify the best therapeutic approach.
at baseline (Day0)
analysis of EWS-CREB1 and EWS-ATF1 mutation and ALK expression on tissue tumor material
Time Frame: 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.
at baseline (Day0)

Collaborators and Investigators

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

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 30, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 25, 2019

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No Individual Patient Data sharing plan has been implemented

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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