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NCT Number: NCT03099681

An Observational Study on Epithelioid Sarcoma

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

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Key information

Conditions

Epithelioid Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST, Meldola, FC, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen
  • Signed informed consent
  • Adequate patient compliance to treatment or follow up
  • No age limit

Exclusion criteria

  • Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent
  • Impossibility to ensure adequate compliance

Treatment and study plan

Treatment for Epitheloid Sarcoma

Other

Treatment Epitheloid Sarcoma according the disease guideline

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Annamaria Frezza, MD

CONTACT

[email protected]

003902390 ext. 2803

Sponsors and collaborators

Lead sponsor

Italian Sarcoma Group

Network

Registry information

Official study title

Epithelioid Sarcoma. An Observational Study

Acronym: EPISObs

Important dates

Study start
2017
Primary completion
2028
Study completion
2030
First posted
Apr 4, 2017
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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