Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Study on Epithelioid Sarcoma (EPISObs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099681
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

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

Condition or disease Intervention/treatment
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epithelioid Sarcoma. An Observational Study
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Type of treatment given to patients with ES [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Tumor sample materiale


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient affected by epithelioid sarcoma according to 2014 WHO classification
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099681


Contacts
Layout table for location contacts
Contact: Annamaria Frezza, MD 003902390 ext 2803 annamaria.frezza@istitutotumori.mi.it

Locations
Layout table for location information
Italy
Istituto Tumori Giovanni Paolo II Not yet recruiting
Bari, BA, Italy, 70124
Contact: Michele Guida, MD    +390805555238    micguida@libero.it   
Principal Investigator: Michele Guida, MD         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST Not yet recruiting
Meldola, FC, Italy
Contact: Toni Ibrahim, MD         
Istituto Europeo di Oncologia Not yet recruiting
Milano, MI, Italy, 20141
Principal Investigator: Tommaso M. De Pas, MD         
Istituto Clinico Humanitas Not yet recruiting
Rozzano, MI, Italy, 20089
Principal Investigator: Rita De Sanctis, MD         
Azienda Ospedaliera Universitaria Paolo Giaccone Not yet recruiting
Palermo, PA, Italy, 90127
Principal Investigator: Antonio Russo, MD         
Azienda Ospedaliera Universitaria Santa Chiara Recruiting
Pisa, PI, Italy, 56124
Contact: Antonella Romanini, MD    +39050543561    a.romanini@ao-pisa.toscana.it   
Principal Investigator: Antonella Romanini, MD         
Centro di Riferimento Oncologico - Unit of Medical Oncology Not yet recruiting
Aviano, Pordenone, Italy, 33081
Contact: Angela Buonadonna, MD       abuonadonna@cro.it   
Contact: Angela, MD         
Sub-Investigator: Angela Buonadonna, MD         
Fondazione del Piemonte per l'Oncologia IRCC Candiolo Not yet recruiting
Candiolo, Torino, Italy, 10060
Principal Investigator: Giovanni Grignani, MD         
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors Recruiting
Bologna, Italy, 40136
Contact: Stefano Ferrari, MD    +390516366199 ext 199    stefano.ferrari@ior.it   
Principal Investigator: Stefano Ferrari, MD         
Azienda Ospedaliero-Universitaria Careggi Not yet recruiting
Firenze, Italy, 50100
Contact: Daniela Greto, MD    + 39055794 ext 111    daniela.greto@gmail.com   
Principal Investigator: Daniela Greto, MD         
Fondazione IRCCS INT Milano Recruiting
Milano, Italy
Contact: Paolo Casali, MD    +390223903 ext 287    paolo.casali@istitutotumori.mi.it   
Principal Investigator: Paolo Casali, MD         
Irccs Istituto Oncologico Veneto (Iov) Not yet recruiting
Padova, Italy
Contact: Antonella Brunello, MD         
Principal Investigator: Antonella Brunello, MD         
Ospedale Misericordia e Dolce Ist. Toscano Tumori, Az. USL4 Not yet recruiting
Prato, Italy, 59100
Principal Investigator: Giacomo G Baldi, MD         
Campus Biomedico Recruiting
Roma, Italy
Contact: Bruno Vincenzi, MD         
Istituti Fisioterapici Ospitalieri di Roma Not yet recruiting
Roma, Italy
Contact: Virginia Ferraresi, MD         
Principal Investigator: Virginia Ferraresi, MD         
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
Layout table for investigator information
Principal Investigator: Paolo Casali, MD Fondazione IRCCS INT Milano
Publications:
Layout table for additonal information
Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT03099681    
Other Study ID Numbers: ISG-EPISObs
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms