EPISObs: An Observational Study on Epithelioid Sarcoma

• Sponsor: Italian Sarcoma Group (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03099681
• Collaborator: (none)
• Enrollment: 100
• Locations: 13
• Anticipated Duration (Months): 63.3
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epithelioid Sarcoma	Other: Treatment for Epitheloid Sarcoma

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Epithelioid Sarcoma. An Observational Study
• Actual Study Start Date: Aug 22, 2017
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Tumori Giovanni Paolo II	Bari	BA	Italy	70124
2	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST	Meldola	FC	Italy
3	Istituto Europeo di Oncologia	Milano	MI	Italy	20141
4	Istituto Clinico Humanitas	Rozzano	MI	Italy	20089
5	Azienda Ospedaliera Universitaria Paolo Giaccone	Palermo	PA	Italy	90127
6	Centro di Riferimento Oncologico - Unit of Medical Oncology	Aviano	Pordenone	Italy	33081
7	Fondazione del Piemonte per l'Oncologia IRCC Candiolo	Candiolo	Torino	Italy	10060
8	Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna		Italy	40136
9	Fondazione IRCCS INT Milano	Milano		Italy
10	Irccs Istituto Oncologico Veneto (Iov)	Padova		Italy
11	Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4	Prato		Italy	59100
12	Campus Biomedico	Roma		Italy
13	Istituti Fisioterapici Ospitalieri di Roma	Roma		Italy

Sponsors and Collaborators

• Italian Sarcoma Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Italian Sarcoma Group
• ClinicalTrials.gov Identifier: NCT03099681
• Other Study ID Numbers: ISG-EPISObs
• First Posted: Apr 4, 2017
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Nov 1, 2021