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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03759327
Other study ID # AFH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2018
Est. completion date May 25, 2019

Study information

Verified date November 2018
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

single institution cases series review of histological and clinical data


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date May 25, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
Italy IRCC Rizzoli Orthopedic Institute Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Antonescu CR, Dal Cin P, Nafa K, Teot LA, Surti U, Fletcher CD, Ladanyi M. EWSR1-CREB1 is the predominant gene fusion in angiomatoid fibrous histiocytoma. Genes Chromosomes Cancer. 2007 Dec;46(12):1051-60. — View Citation

Bohman SL, Goldblum JR, Rubin BP, Tanas MR, Billings SD. Angiomatoid fibrous histiocytoma: an expansion of the clinical and histological spectrum. Pathology. 2014 Apr;46(3):199-204. doi: 10.1097/PAT.0000000000000073. — View Citation

Chen G, Folpe AL, Colby TV, Sittampalam K, Patey M, Chen MG, Chan JK. Angiomatoid fibrous histiocytoma: unusual sites and unusual morphology. Mod Pathol. 2011 Dec;24(12):1560-70. doi: 10.1038/modpathol.2011.126. Epub 2011 Aug 5. — View Citation

Noujaim J, Jones RL, Swansbury J, Gonzalez D, Benson C, Judson I, Fisher C, Thway K. The spectrum of EWSR1-rearranged neoplasms at a tertiary sarcoma centre; assessing 772 tumour specimens and the value of current ancillary molecular diagnostic modalities — View Citation

Rossi S, Szuhai K, Ijszenga M, Tanke HJ, Zanatta L, Sciot R, Fletcher CD, Dei Tos AP, Hogendoorn PC. EWSR1-CREB1 and EWSR1-ATF1 fusion genes in angiomatoid fibrous histiocytoma. Clin Cancer Res. 2007 Dec 15;13(24):7322-8. — View Citation

Outcome

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