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Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series

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ClinicalTrials.gov Identifier: NCT03759327
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Brief Summary:
single institution cases series review of histological and clinical data

Condition or disease
Angiomatoid Fibrous Histiocytoma

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.

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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
immunohistochemistry will be performed on FFPE material. EWS-CREB1 and EWS-ATF1 mutation and ALK expression will be analyzed with RT-PCR and/or FISH analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
Criteria

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


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): NCT03759327


Contacts
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Contact: Marco Gambarotti +39051.63.66 ext 652 marco.gambarotti@ior.it

Sponsors and Collaborators
Istituto Ortopedico Rizzoli
  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] September 3, 2018


Publications of Results:
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03759327     History of Changes
Other Study ID Numbers: AFH
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Individual Patient Data sharing plan has been implemented

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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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Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma