Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05640960
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2022-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018197', 'term': 'Hepatoblastoma'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received', 'timeFrame': '3 years after treatment', 'description': 'the primary endpoint is event-free survival (progression, death, relapse) at 3 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Embryonal Sarcoma', 'Embryonic Sarcoma', 'Hepatoblastoma', 'Hepatocarcinoma', 'Hepatic Sarcoma', 'Undifferentiated (Embryonal) Sarcoma'], 'conditions': ['Hepatic Sarcoma']}, 'descriptionModule': {'briefSummary': '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.\n\nIt seems appropriate to review the management of these tumors in France in order to discuss the best therapeutic strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient aged 0 to 25 with treatment carried out in France from 01/01/2008 to 31/12/2018', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Any patient aged 0 to 25 on the date of inclusion in the study\n* Treatment carried out in France (included in NRSTS 2005, in the childhood cancer registry or in an SFCE center)\n* Start of treatment from 01/01/2008 to 31/12/2018\n* Diagnosis of undifferentiated embryonal sarcoma of the liver defined by a compatible histological analysis\n* Adult subject who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research\n* 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\n\nExclusion criteria:\n\n* Refusal to participate in this research\n* Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET\n* Absence of histological and/or molecular documentation.'}, 'identificationModule': {'nctId': 'NCT05640960', 'acronym': 'SARCOM', 'briefTitle': 'Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Undifferentiated Embryonal Sarcoma of the Liver', 'orgStudyIdInfo': {'id': '7979'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service Pédiatrie Onco-hématologie - Pédiatrie III - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}