An Observational Study on Epithelioid Sarcoma

Epithelioid Sarcoma. An Observational Study

Sponsors

Lead Sponsor: Italian Sarcoma Group

Source Italian Sarcoma Group
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.

Overall Status Recruiting
Start Date August 22, 2017
Completion Date December 1, 2020
Primary Completion Date May 1, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Type of treatment given to patients with ES From diagnosis until the date of death from any cause assessed up to 60 months
Secondary Outcome
Measure Time Frame
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
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: Treatment for Epitheloid Sarcoma

Description: Treatment Epitheloid Sarcoma according the disease guideline

Arm Group Label: Epitheloid Sarcoma patients

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Paolo Casali, MD Principal Investigator Fondazione IRCCS INT Milano
Overall Contact

Last Name: Annamaria Frezza, MD

Phone: 003902390

Phone Ext.: 2803

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Istituto Tumori Giovanni Paolo II | Bari, BA, 70124, Italy Not yet recruiting Michele Guida, MD +390805555238 [email protected] Michele Guida, MD Principal Investigator
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST | Meldola, FC, Italy Not yet recruiting Toni Ibrahim, MD
Istituto Europeo di Oncologia | Milano, MI, 20141, Italy Not yet recruiting Tommaso M. De Pas, MD Principal Investigator
Istituto Clinico Humanitas | Rozzano, MI, 20089, Italy Not yet recruiting Rita De Sanctis, MD Principal Investigator
Azienda Ospedaliera Universitaria Paolo Giaccone | Palermo, PA, 90127, Italy Not yet recruiting Antonio Russo, MD Principal Investigator
Azienda Ospedaliera Universitaria Santa Chiara | Pisa, PI, 56124, Italy Recruiting Antonella Romanini, MD +39050543561 [email protected] Antonella Romanini, MD Principal Investigator
Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano, Pordenone, 33081, Italy Not yet recruiting Angela Buonadonna, MD [email protected] Angela Buonadonna, MD Sub-Investigator
Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo, Torino, 10060, Italy Not yet recruiting Giovanni Grignani, MD Principal Investigator
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors | Bologna, 40136, Italy Recruiting Stefano Ferrari, MD +390516366199 199 [email protected] Stefano Ferrari, MD Principal Investigator
Azienda Ospedaliero-Universitaria Careggi | Firenze, 50100, Italy Not yet recruiting Daniela Greto, MD + 39055794 111 [email protected] Daniela Greto, MD Principal Investigator
Fondazione IRCCS INT Milano | Milano, Italy Recruiting Paolo Casali, MD +390223903 287 [email protected] Paolo Casali, MD Principal Investigator
Irccs Istituto Oncologico Veneto (Iov) | Padova, Italy Not yet recruiting Antonella Brunello, MD Antonella Brunello, MD Principal Investigator
Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4 | Prato, 59100, Italy Not yet recruiting Giacomo G Baldi, MD Principal Investigator
Campus Biomedico | Roma, Italy Recruiting Bruno Vincenzi, MD
Istituti Fisioterapici Ospitalieri di Roma | Roma, Italy Not yet recruiting Virginia Ferraresi, MD Virginia Ferraresi, MD Principal Investigator
Location Countries

Italy

Verification Date

February 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Epitheloid Sarcoma patients

Description: Patients with diagnosis of localized or advanced epitheloid sarcoma seen in the Italian reference centers for sarcoma treatment that receive treatment for Epitheloid Sarcoma

Acronym EPISObs
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov