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Epithelioid SarcomaEPISObsNCT03099681

An Observational Study on Epithelioid Sarcoma

An observational study of Epithelioid Sarcoma, run by Italian Sarcoma Group at 11 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES) Read more about this study

Who is it for?
Any age
Conditions the study is for
Epithelioid Sarcoma
What is being tested?
Treatment for Epitheloid Sarcoma
How many people
100 participants
Where
11 sitesItaly
Study dates
22 Aug 2017to 31 Mar 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient affected by epithelioid sarcoma according to 2014 WHO classification

Who may be able to join

  • Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen
  • Signed informed consent
  • Adequate patient compliance to treatment or follow up
  • No age limit

Who cannot join

  • Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent
  • Impossibility to ensure adequate compliance

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Annamaria Frezza, MD contact

003902390 ext. 2803

annamaria.frezza@istitutotumori.mi.it

11 sites in 1 country

Italy11 sites, 11 recruiting

  • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

    Bologna, 40136

    Emanuela Palmerini, MD, +390516366199 ext. 199, emanuela.palmerini@ior.it

    Emanuela Palmerini, MD

    Recruiting

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, Torino, 10060

    Giovanni Grignani, MD

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

    Meldola, FC

    Lorella Gurreri, MD

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

    Elisabetta Setola, MD

    Recruiting

  • Fondazione IRCCS INT Milano

    Milan

    Paolo Casali, MD, +390223903 ext. 287, paolo.casali@istitutotumori.mi.it

    Paolo Casali, MD

    Recruiting

  • Irccs Istituto Oncologico Veneto (Iov)

    Padova

    Antonella Brunello, MD

    Antonella Brunello, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Paolo Giaccone

    Palermo, PA, 90127

    Antonio Russo, MD

    Recruiting

  • Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4

    Prato, 59100

    Giacomo G Baldi, MD

    Recruiting

  • Campus Biomedico

    Roma

    Bruno Vincenzi, MD

    Recruiting

  • Istituti Fisioterapici Ospitalieri di Roma

    Roma

    Virginia Ferraresi, MD

    Virginia Ferraresi, MD

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

    Alexia Bertulli, MD

    Recruiting

Other trials in Italy

About this study

Official title: Epithelioid Sarcoma. An Observational Study

Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES)

Read the detailed description

The present prospective national study aims to provide a description of the population affected by ES, an insight into the natural history of the disease and an answer some on the outstanding questions on its management. Also, it will focus on enhancing any differences between the two ES variants (classical-type and proximal-type) in order gain a better understanding of the disease, tailor the treatment and lastly improve outcome.

Being tested
Treatment for Epitheloid Sarcoma
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment for Epitheloid SarcomaOther

    Treatment Epitheloid Sarcoma according the disease guideline

Study groups in NCT03099681
Study groupRoleWhat they receive
Epitheloid Sarcoma patientsPatients with diagnosis of localized or advanced epitheloid sarcoma seen in the Italian reference centers for sarcoma treatment that receive treatment for Epitheloid Sarcoma
Receives: Other: Treatment for Epitheloid Sarcoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type of treatment given to patients with ES

    Number of chemotherapy treatment received patients affected by ES

    Measured: From diagnosis until the date of death from any cause assessed up to 60 months

Secondary outcomes (3)

  1. Radiotherapy treatments

    Number of patients affected by localized ES who received radiotherapy

    Measured: From the time of diagnosis and then every 6 months up to 60 months

  2. Chemotherapy treatments

    Number of patients affected by localized ES who received chemotherapy

    Measured: From the time of diagnosis and then every 6 months up to 60 months

  3. Predictive biomarkers for response

    Tumor biomarkers expression in tumor tissue of patients affected by ES

    Measured: At time of diagnosis and at the time of any progression where a biopsy is performed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start22 Aug 2017
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099681
Sponsor's protocol ID
ISG-EPISObs
Acronym
EPISObs
Status last verified
Nov 2025
First submitted
17 Mar 2017
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thway K, Jones RL, Noujaim J, Fisher C. Epithelioid Sarcoma: Diagnostic Features and Genetics. Adv Anat Pathol. 2016 Jan;23(1):41-9. doi: 10.1097/PAP.0000000000000102.

    PubMed 26645461

  • Guillou L, Wadden C, Coindre JM, Krausz T, Fletcher CD. "Proximal-type" epithelioid sarcoma, a distinctive aggressive neoplasm showing rhabdoid features. Clinicopathologic, immunohistochemical, and ultrastructural study of a series. Am J Surg Pathol. 1997 Feb;21(2):130-46. doi: 10.1097/00000478-199702000-00002.

    PubMed 9042279

  • Chase DR, Enzinger FM. Epithelioid sarcoma. Diagnosis, prognostic indicators, and treatment. Am J Surg Pathol. 1985 Apr;9(4):241-63.

    PubMed 4014539

  • Bos GD, Pritchard DJ, Reiman HM, Dobyns JH, Ilstrup DM, Landon GC. Epithelioid sarcoma. An analysis of fifty-one cases. J Bone Joint Surg Am. 1988 Jul;70(6):862-70.

    PubMed 3392084

  • Halling AC, Wollan PC, Pritchard DJ, Vlasak R, Nascimento AG. Epithelioid sarcoma: a clinicopathologic review of 55 cases. Mayo Clin Proc. 1996 Jul;71(7):636-42. doi: 10.1016/S0025-6196(11)63000-0.

    PubMed 8656704

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelioid Sarcoma, run by Italian Sarcoma Group at 11 sites 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 2 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annamaria Frezza, MD (003902390 ext. 2803, annamaria.frezza@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type of treatment given to patients with ES (time frame: From diagnosis until the date of death from any cause assessed up to 60 months). 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 NCT03099681, 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 18 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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