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An Observational Study on Epithelioid Sarcoma (EPISObs)

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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

Tracking Information
First Submitted Date March 17, 2017
First Posted Date April 4, 2017
Last Update Posted Date July 28, 2020
Actual Study Start Date August 22, 2017
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study on Epithelioid Sarcoma
Official Title Epithelioid Sarcoma. An Observational Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor sample materiale
Sampling Method Non-Probability Sample
Study Population Patient affected by epithelioid sarcoma according to 2014 WHO classification
Condition Epithelioid Sarcoma
Intervention Other: Treatment for Epitheloid Sarcoma
Treatment Epitheloid Sarcoma according the disease guideline
Study Groups/Cohorts 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
Intervention: Other: Treatment for Epitheloid Sarcoma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 28, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Annamaria Frezza, MD 003902390 ext 2803 annamaria.frezza@istitutotumori.mi.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03099681
Other Study ID Numbers ISG-EPISObs
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Italian Sarcoma Group
Study Sponsor Italian Sarcoma Group
Collaborators Not Provided
Investigators
Principal Investigator: Paolo Casali, MD Fondazione IRCCS INT Milano
PRS Account Italian Sarcoma Group
Verification Date July 2020