Hepatic SarcomaSARCOMNCT05640960
Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered
An observational study of Hepatic Sarcoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Hepatic Sarcoma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- Child, Adult
Study population: Patient aged 0 to 25 with treatment carried out in France from 01/01/2008 to 31/12/2018
Who may be able to join
- 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
Who cannot join
- Refusal to participate in this research
- Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET
- Absence of histological and/or molecular documentation.
Trial locations and contacts
1 site in 1 country.
France1 site
Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Hepatic Sarcoma
- Keywords
- Embryonal Sarcoma, Embryonic Sarcoma, Hepatoblastoma, Hepatocarcinoma, Hepatic Sarcoma, Undifferentiated (Embryonal) Sarcoma
- Medical subject headings
- Hepatoblastoma, Carcinoma, Hepatocellular, Disorders of Sex Development, Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start11 Sep 2020
- Primary completion11 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SarcomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640960
- Sponsor's protocol ID
- 7979
- Acronym
- SARCOM
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undifferentiated Embryonal Sarcoma of the Liver
- ClinicalTrials.gov ID
- NCT05640960
- Acronym / sponsor ID
- SARCOM / 7979
- Conditions
- Hepatic Sarcoma
- Keywords
- Embryonal Sarcoma, Embryonic Sarcoma, Hepatoblastoma, Hepatocarcinoma, Hepatic Sarcoma, Undifferentiated (Embryonal) Sarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patient aged 0 to 25 with treatment carried out in France from 01/01/2008 to 31/12/2018
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Refusal to participate in this research
- Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET
- Absence of histological and/or molecular documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received
Time frame: 3 years after treatment
the primary endpoint is event-free survival (progression, death, relapse) at 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Sarcoma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received (time frame: 3 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.