An Observational Study on Epithelioid Sarcoma

Epithelioid Sarcoma Clinical Trial

— EPISObs  

Official title:

Epithelioid Sarcoma. An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03099681
• Other study ID #: ISG-EPISObs
• Status: Recruiting
• Start date: August 22, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: Italian Sarcoma Group
• Contact: Annamaria Frezza, MD
• Phone: 003902390
• Email: annamaria.frezza[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epithelioid Sarcoma
• Sarcoma

Intervention

Other:
• Treatment for Epitheloid Sarcoma
Treatment Epitheloid Sarcoma according the disease guideline

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna
Italy	Fondazione del Piemonte per l'Oncologia IRCC Candiolo	Candiolo	Torino
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST	Meldola	FC
Italy	Fondazione IRCCS INT Milano	Milano
Italy	Istituto Europeo di Oncologia	Milano	MI
Italy	Irccs Istituto Oncologico Veneto (Iov)	Padova
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone	Palermo	PA
Italy	Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4	Prato
Italy	Campus Biomedico	Roma
Italy	Istituti Fisioterapici Ospitalieri di Roma	Roma
Italy	Istituto Clinico Humanitas	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiotherapy treatments	Number of patients affected by localized ES who received radiotherapy	From the time of diagnosis and then every 6 months up to 60 months
Secondary	Chemotherapy treatments	Number of patients affected by localized ES who received chemotherapy	From the time of diagnosis and then every 6 months up to 60 months
Secondary	Predictive biomarkers for response	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