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CompletedNCT05640960SARCOMUpdated Dec 8, 2023

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

An observational study in Hepatic Sarcoma, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 1 Year to 25 Years. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
1 Year to 25 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatic Sarcoma

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Keywords

  • Embryonal Sarcoma
  • Embryonic Sarcoma
  • Hepatoblastoma
  • Hepatocarcinoma
  • Hepatic Sarcoma
  • Undifferentiated (Embryonal) Sarcoma
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 30 is below the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 25 Years
Sexes eligible
All
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

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

Exclusion criteria:

  • Refusal to participate in this research
  • Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET
  • Absence of histological and/or molecular documentation.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years after treatment

07

Study locations

1 site
  • Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France
    Strasbourg, 67091, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05640960
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Sep 11, 2020
Primary completion
Nov 11, 2021
Completion
Dec 31, 2021
Last update
Dec 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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