An Observational Study on Epithelioid Sarcoma

Recruiting

• Conditions: Epithelioid Sarcoma
• Interventions: Other: Treatment for Epitheloid Sarcoma

• Registration Number: NCT03099681
• Lead Sponsor: Italian Sarcoma Group

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-08-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-11-01
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epitheloid Sarcoma patients	Treatment for Epitheloid Sarcoma	Patients with diagnosis of localized or advanced epitheloid sarcoma seen in the Italian reference centers for sarcoma treatment that receive treatment for Epitheloid Sarcoma

Primary Outcome Measures

Name	Time	Method
Type of treatment given to patients with ES	From diagnosis until the date of death from any cause assessed up to 60 months	Number of chemotherapy treatment received patients affected by ES

Secondary Outcome Measures

Name	Time	Method
Predictive biomarkers for response	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
Radiotherapy treatments	From the time of diagnosis and then every 6 months up to 60 months	Number of patients affected by localized ES who received radiotherapy
Chemotherapy treatments	From the time of diagnosis and then every 6 months up to 60 months	Number of patients affected by localized ES who received chemotherapy

Trial Locations

Locations (11)

Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors; 🇮🇹 Bologna, Italy

Fondazione IRCCS INT Milano; 🇮🇹 Milano, Italy

Campus Biomedico; 🇮🇹 Roma, Italy

Irccs Istituto Oncologico Veneto (Iov); 🇮🇹 Padova, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone; 🇮🇹 Palermo, PA, Italy

Istituti Fisioterapici Ospitalieri di Roma; 🇮🇹 Roma, Italy

Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4; 🇮🇹 Prato, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST; 🇮🇹 Meldola, FC, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Italy

Istituto Europeo di Oncologia; 🇮🇹 Milano, MI, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo; 🇮🇹 Candiolo, Torino, Italy