NCT03759327

Brief Summary

single institution cases series review of histological and clinical data

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2019

Completed
Last Updated

February 13, 2020

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 22, 2018

Last Update Submit

February 11, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with histological diagnosis different from Angiomatoid Fibrous Histiocytoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCC Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Location

Related 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. doi: 10.1002/gcc.20491.

  • 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.

  • 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.

  • 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. Br J Cancer. 2017 Feb 28;116(5):669-678. doi: 10.1038/bjc.2017.4. Epub 2017 Jan 31.

  • 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. doi: 10.1158/1078-0432.CCR-07-1744.

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.

MeSH Terms

Conditions

Histiocytoma, Angiomatoid Fibrous

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 30, 2018

Study Start

November 30, 2018

Primary Completion

May 1, 2019

Study Completion

May 25, 2019

Last Updated

February 13, 2020

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

No Individual Patient Data sharing plan has been implemented

Locations