An Observational Study on Epithelioid Sarcoma (EPISObs)

November 17, 2025 updated by: Italian Sarcoma Group

Epithelioid Sarcoma. An Observational Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
        • Contact:
        • Principal Investigator:
          • Emanuela Palmerini, MD
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS INT Milano
        • Contact:
        • Principal Investigator:
          • Paolo Casali, MD
      • Padua, Italy
        • Recruiting
        • IRCCS Istituto Oncologico Veneto (IOV)
        • Contact:
          • Antonella Brunello, MD
        • Principal Investigator:
          • Antonella Brunello, MD
      • Prato, Italy, 59100
        • Recruiting
        • Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4
        • Principal Investigator:
          • Giacomo G Baldi, MD
      • Roma, Italy
        • Recruiting
        • Campus Biomedico
        • Contact:
          • Bruno Vincenzi, MD
      • Roma, Italy
        • Recruiting
        • Istituti Fisioterapici Ospitalieri di Roma
        • Contact:
          • Virginia Ferraresi, MD
        • Principal Investigator:
          • Virginia Ferraresi, MD
    • FC
      • Meldola, FC, Italy
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
        • Contact:
          • Lorella Gurreri, MD
    • MI
      • Milan, MI, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Elisabetta Setola, MD
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Principal Investigator:
          • Alexia Bertulli, MD
    • PA
      • Palermo, PA, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Paolo Giaccone
        • Principal Investigator:
          • Antonio Russo, MD
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia IRCC Candiolo
        • Principal Investigator:
          • Giovanni Grignani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient affected by epithelioid sarcoma according to 2014 WHO classification

Description

Inclusion criteria

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

Exclusion criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epitheloid Sarcoma patients
Patients with diagnosis of localized or advanced epitheloid sarcoma seen in the Italian reference centers for sarcoma treatment that receive treatment for Epitheloid Sarcoma
Other: Treatment for Epitheloid Sarcoma
Treatment Epitheloid Sarcoma according the disease guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Number of chemotherapy treatment received patients affected by ES
From diagnosis until the date of death from any cause assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiotherapy treatments
Time Frame: From the time of diagnosis and then every 6 months up to 60 months
Number of patients affected by localized ES who received radiotherapy
From the time of diagnosis and then every 6 months up to 60 months
Chemotherapy treatments
Time Frame: From the time of diagnosis and then every 6 months up to 60 months
Number of patients affected by localized ES who received chemotherapy
From the time of diagnosis and then every 6 months up to 60 months
Predictive biomarkers for response
Time Frame: At time of diagnosis and at the time of any progression where a biopsy is performed up to 60 months
Tumor biomarkers expression in tumor tissue of patients affected by ES
At time of diagnosis and at the time of any progression where a biopsy is performed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Investigators

  • Principal Investigator: Paolo Casali, MD, Fondazione IRCCS INT Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2017

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG-EPISObs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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