Angiomatoid Fibrous HistiocytomaNCT03759327
Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series
An observational study of Angiomatoid Fibrous Histiocytoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
single institution cases series review of histological and clinical data Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angiomatoid Fibrous Histiocytoma
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2018to 25 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with histological diagnosis different from Angiomatoid Fibrous Histiocytoma
Trial locations and contacts
1 site in 1 country.
About this study
single institution cases series review of histological and clinical data
Read the 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.
- Conditions
- Angiomatoid Fibrous Histiocytoma
- Medical subject headings
- Histiocytoma, Angiomatoid Fibrous
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start30 Nov 2018
- Primary completion1 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Angiomatoid Fibrous HistiocytomaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759327
- Sponsor's protocol ID
- AFH
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Individual Patient Data sharing plan has been implemented
Publications
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.
PubMed 17724745Bohman 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.
PubMed 24614712Chen 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.
PubMed 21822206Noujaim 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.
PubMed 28141799Rossi 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.
PubMed 18094413
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiomatoid Fibrous Histiocytoma: a Single Institution Case-series
- ClinicalTrials.gov ID
- NCT03759327
- Acronym / sponsor ID
- AFH
- Conditions
- Angiomatoid Fibrous Histiocytoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
single institution cases series review of histological and clinical data
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
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with histological diagnosis different from Angiomatoid Fibrous Histiocytoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Results publication: PubMed 17724745Antonescu 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.
- Results publication: PubMed 24614712Bohman 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.
- Results publication: PubMed 21822206Chen 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.
- Results publication: PubMed 28141799Noujaim 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.
- Results publication: PubMed 18094413Rossi 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.
- Individual participant dataSharing planned: No. No Individual Patient Data sharing plan has been implemented
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angiomatoid Fibrous Histiocytoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
selection and review of 9 cases of Angiomatoid Fibrous Histiocytoma (time frame: at baseline (Day0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759327, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.