An Observational Study on Epithelioid Sarcoma

NCT03099681 — Recruiting, 100 participants, Italian Sarcoma Group

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Epithelioid Sarcoma. An Observational Study

RegistryNCT03099681, acronym EPISObs
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorItalian Sarcoma Group (Network)
ConditionsEpithelioid Sarcoma
InterventionsTreatment for Epitheloid Sarcoma (Other)
Datesstart 2017-08-22, primary completion 2028-11-01 (estimated), completion 2030-03-31 (estimated), first posted 2017-04-04, last updated 2025-11-18
Locations11 sites in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Epithelioid Sarcoma All trials of Treatment for Epitheloid Sarcoma

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Epitheloid Sarcoma patientsOther: Treatment for Epitheloid SarcomaPatients with diagnosis of localized or advanced epitheloid sarcoma seen in the Italian reference centers for sarcoma treatment that receive treatment for Epitheloid Sarcoma
  • Treatment for Epitheloid Sarcoma (Other): Treatment Epitheloid Sarcoma according the disease guideline

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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
  • 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

Sex: All

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

+Locations (11)

FacilityCityCountryStatus
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRSTMeldola, FCItalyRecruiting
Istituto Europeo di OncologiaMilan, MIItalyRecruiting
Istituto Clinico HumanitasRozzano, MIItalyRecruiting
Azienda Ospedaliera Universitaria Paolo GiacconePalermo, PAItalyRecruiting
Fondazione del Piemonte per l'Oncologia IRCC CandioloCandiolo, TorinoItalyRecruiting
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal TumorsBolognaItalyRecruiting
Fondazione IRCCS INT MilanoMilanItalyRecruiting
Irccs Istituto Oncologico Veneto (Iov)PadovaItalyRecruiting
Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4PratoItalyRecruiting
Campus BiomedicoRomaItalyRecruiting
Istituti Fisioterapici Ospitalieri di RomaRomaItalyRecruiting

+Publications

  • 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
  • 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
  • Chase DR, Enzinger FM. Epithelioid sarcoma. Diagnosis, prognostic indicators, and treatment. Am J Surg Pathol. 1985 Apr;9(4):241-63. PMID 4014539
  • 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
  • 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

+Investigators