Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-09 @ 7:49 PM
Study NCT ID:
NCT06870461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2024-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Excision and Ablation Log
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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2040-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishment of a Liver Surgery and Ablation Registry', 'timeFrame': '10 years', 'description': 'The primary objective of this study is to create a comprehensive registry of patients who have undergone liver surgery or liver ablation. This registry will serve as a foundation for future epidemiological studies, enabling the assessment of long-term outcomes, the identification of risk factors, and the evaluation of potential therapeutic interventions. Data collected will include demographic information, medical history, surgical details, postoperative outcomes, and survival rates. By compiling this data, we aim to better understand the patient population and improve care for individuals undergoing liver surgery or ablation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Liver Tumor', 'Benign Liver Tumor']}, 'descriptionModule': {'briefSummary': 'This study aims to establish a registry for liver surgery and ablation procedures to improve patient care, advance research, and enhance surgical quality. The registry will collect pseudonymized data on patient demographics, disease characteristics, procedural details, and outcomes.', 'detailedDescription': "The purpose of this registry is to create a comprehensive list of individuals who have undergone liver surgery or liver ablation, allowing researchers and clinicians to assess their data in future studies if they meet the eligibility criteria. All patients who have received liver surgery or liver ablation procedures at our institution will be included in this registry.\n\nInformation collected as part of the registry will be used solely to assess potential participants' eligibility for research studies, allowing for the evaluation of long-term outcomes, identification of risk factors, and investigation of therapeutic interventions. This data will help to enhance the understanding of the patient population undergoing liver surgery and improve clinical practices.\n\nA patient registry is an organized system that uses observational study methods to collect standardized clinical data and other relevant information. It aims to evaluate specific outcomes for individuals who have undergone liver surgery or ablation, serving scientific, clinical, and policy-related purposes. The registry will support the development of targeted research studies and provide valuable insights into the treatment and management of liver diseases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who will undergo liver surgery or ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both benign and malignant liver lesions are included\n\nExclusion Criteria:\n\n\\- Intervention performed solely for liver biopsy, without any subsequent surgical resection or ablation.'}, 'identificationModule': {'nctId': 'NCT06870461', 'acronym': 'HEAL', 'briefTitle': 'Hepatic Excision and Ablation Log', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Hepatic Excision and Ablation Log', 'orgStudyIdInfo': {'id': '003810'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liver surgery / ablation', 'type': 'PROCEDURE', 'description': 'Any type of liversurgery or CT-guidede liver ablation'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bart Hendrikx', 'role': 'CONTACT', 'email': 'hepatobiliaireheelkunde@uza.be', 'phone': '+3238214327'}], 'overallOfficials': [{'name': 'Thiery Chapelle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}