Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered (SARCOM)

Undifferentiated Embryonal Sarcoma of the Liver

Undifferentiated embryonal sarcoma of the liver is the 3rd most common malignant liver tumor after hepatoblastoma and hepatocellular carcinoma with a peak incidence between 6 and 10 years of age. Historically, it is a tumor treated only by surgery with a poor prognosis. In the last decade, the combination of more intensive chemotherapy and, more randomly, radiotherapy, has significantly improved the survival rate of these patients. Due to its low incidence, there are few series reported in the literature and to date there is no specific treatment protocol for the management of these tumors.

It seems appropriate to review the management of these tumors in France in order to discuss the best therapeutic strategy.

Study Overview

• Status: Completed
• Conditions: Hepatic Sarcoma

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 25 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient aged 0 to 25 with treatment carried out in France from 01/01/2008 to 31/12/2018

Description

Inclusion criteria:

• Any patient aged 0 to 25 on the date of inclusion in the study
• Treatment carried out in France (included in NRSTS 2005, in the childhood cancer registry or in an SFCE center)
• Start of treatment from 01/01/2008 to 31/12/2018
• Diagnosis of undifferentiated embryonal sarcoma of the liver defined by a compatible histological analysis
• Adult subject who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research
• Minor subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

• Refusal to participate in this research
• Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET
• Absence of histological and/or molecular documentation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received	the primary endpoint is event-free survival (progression, death, relapse) at 3 years.	3 years after treatment

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hepatocarcinoma; Hepatoblastoma; Embryonal Sarcoma; Embryonic Sarcoma; Hepatic Sarcoma; Undifferentiated (Embryonal) Sarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: 7979

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No