An Observational Study on Epithelioid Sarcoma

NCT03099681 | Recruiting

• 1 other identifier: ISG-EPISObs
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Epithelioid Sarcoma

Outcome Measures

Primary Outcomes (1)

• Type of treatment given to patients with ES

  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 Outcomes (3)

• Radiotherapy treatments

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

• Chemotherapy treatments

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

• Predictive biomarkers for response

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

Study Arms (1)

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

Interventions

Treatment for Epitheloid Sarcoma OTHER

Treatment Epitheloid Sarcoma according the disease guideline

Epitheloid Sarcoma patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient affected by epithelioid sarcoma according to 2014 WHO classification

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (11)

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

Meldola, FC, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, 90127, Italy

RECRUITING

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, Italy

RECRUITING

Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, 40136, Italy

RECRUITING

Fondazione IRCCS INT Milano

Milan, Italy

RECRUITING

Irccs Istituto Oncologico Veneto (Iov)

Padua, Italy

RECRUITING

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

Prato, 59100, Italy

RECRUITING

Campus Biomedico

Roma, Italy

RECRUITING

Istituti Fisioterapici Ospitalieri di Roma

Roma, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 26645461 BACKGROUND

• 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.

  PMID: 9042279 BACKGROUND

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

  PMID: 4014539 BACKGROUND

• 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.

  PMID: 3392084 BACKGROUND

• 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.

  PMID: 8656704 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor sample materiale

MeSH Terms

Conditions

Sarcoma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Paolo Casali, MD

  Fondazione IRCCS INT Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annamaria Frezza, MD

CONTACT

003902390; annamaria.frezza@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 4, 2017
• Study Start: August 22, 2017
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (11)