Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT04274868
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2020-02-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric Hepatic Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish a national bank of rare biological material', 'timeFrame': 'Up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Tumor']}, 'descriptionModule': {'briefSummary': 'Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated after 01/01/1990 for a primary liver tumor before the age of 18.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\- For inclusion in the clinical database:\n\n * Children and adolescents (≤18 years at diagnosis) suffering from a primary liver tumor diagnosed after 01/01/1990 and treated in France\n * Informed consent to the computerization of data signed by the patient or by parents or legal representatives if he is a minor.\n2. \\- For inclusion in the biological collection (CRB Paris Sud):\n\n * Additional criteria:\n * Availability of biological samples (tumor tissue, healthy tissue, plasma and / or serum).\n * Informed consent to the use of biological remains signed by the patient or by parents or legal representatives if he is a minor.\n3. \\- For the inclusion of deceased patients:\n\n * Obtaining consent or failing this, seeking non-opposition to the computerization of data (for inclusion in the database) and the use of biological remains (for inclusion in the biological collection) of the patient or both parents or the legal guardian if he is a minor.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04274868', 'acronym': 'HEPATOBIO', 'briefTitle': 'Pediatric Hepatic Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Constitution of a Centralized Biological Resources Collection and Associated With a Clinical Database for Childhood Liver Tumors Diagnosed in France (Retrospective Collection From 1990 and Prospective)', 'orgStudyIdInfo': {'id': '2015-A00180-49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children and adolescents with liver tumor', 'description': 'Patients treated after 01/01/1990 for a primary liver tumor before the age of 18.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94800', 'city': 'Villejuif', 'state': 'Val De Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Branda Mallon', 'role': 'CONTACT', 'email': 'branda.mallon@gustaveroussy.fr', 'phone': '0142114211', 'phoneExt': '+33'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Brenda Mallon', 'role': 'CONTACT', 'email': 'branda.mallon@gustaveroussy.fr', 'phone': '0142114211', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}