Clinical trial NCT03099681: An Observational Study on Epithelioid Sarcoma
Official title: Epithelioid Sarcoma. An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epithelioid Sarcoma
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2017-04-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient affected by epithelioid sarcoma according to 2014 WHO classification

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.

Eligibility criteria: 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

Primary outcomes:
measure: Type of treatment given to patients with ES
timeFrame: From diagnosis until the date of death from any cause assessed up to 60 months
Secondary outcomes:
measure: Radiotherapy treatments
timeFrame: From the time of diagnosis and then every 6 months up to 60 months
measure: Chemotherapy treatments
timeFrame: From the time of diagnosis and then every 6 months up to 60 months
measure: Predictive biomarkers for response
timeFrame: At time of diagnosis and at the time of any progression where a biopsy is performed up to 60 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
state: FC
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone
state: PA
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo
state: Torino
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
city: Milano
country: Italy
facility: Fondazione IRCCS INT Milano
city: Padova
country: Italy
facility: Irccs Istituto Oncologico Veneto (Iov)
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4
city: Roma
country: Italy
facility: Campus Biomedico
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri di Roma
Study officials:
affiliation: Fondazione IRCCS INT Milano
name: Paolo Casali, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Chase DR, Enzinger FM. Epithelioid sarcoma. Diagnosis, prognostic indicators, and treatment. Am J Surg Pathol. 1985 Apr;9(4):241-63.
citation: 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.
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.