Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-01 @ 7:35 AM
Study NCT ID:
NCT04553458
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2020-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D006498', 'term': 'Hepatectomy'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-11', 'studyFirstSubmitDate': '2020-09-05', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CURE (Number of patients cured completely from the disease)', 'timeFrame': 'one-year', 'description': 'the HCC is treated (disappearance of all lesions)'}, {'measure': 'STABLE Disease (Number of patients with neither progression nor cure from the disease)', 'timeFrame': 'one-year', 'description': "NONE of the other outcomes' criteria"}, {'measure': 'PROGRESSIVE((Number of patients with progression of the disease) (measured by follow-up CT scans, increase in size, appearance of new intratumoral lesions, or appearance of new lesions', 'timeFrame': 'one-year', 'description': 'increase in size - appearance of new intratumoral lesions - new lesions'}], 'secondaryOutcomes': [{'measure': 'DEATH (Number of patients died from the disease)', 'timeFrame': 'one-year', 'description': 'Mortality rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'HCC', 'Hepatoma', 'primary liver tumours'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \\< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.', 'detailedDescription': "Background:\n\nEASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus \\< = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.\n\nMethods:\n\nThis work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).\n\nDuring the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* with hepatocellular carcinoma\n\nExclusion Criteria:\n\n* severely-ill patients\n* With other system comorbidities,\n* presence of extrahepatic metastasis,\n* patients who dropped from the follow-up list after treatment.'}, 'identificationModule': {'nctId': 'NCT04553458', 'briefTitle': 'Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '22/09/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Favorable outcome', 'description': 'Cure or stable disease', 'interventionNames': ['Device: Radiofrequency ablation', 'Drug: Trance-arterial chemoembolization', 'Procedure: Liver resection', 'Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection', 'Drug: Percutaneous ethanol injection']}, {'label': 'Unfavorable outcome', 'description': 'Progressive (deteriorate/Recurrence) or Death', 'interventionNames': ['Device: Radiofrequency ablation', 'Drug: Trance-arterial chemoembolization', 'Combination Product: Combined radiofrequency ablation + percutaneous ethanol injection', 'Drug: Percutaneous ethanol injection', 'Drug: Systemic chemotherapy', 'Drug: Sorafenib', 'Dietary Supplement: Viscum', 'Drug: Symptomatic treatment']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'DEVICE', 'description': 'Radiofrequency ablation of the tumour', 'armGroupLabels': ['Favorable outcome', 'Unfavorable outcome']}, {'name': 'Trance-arterial chemoembolization', 'type': 'DRUG', 'otherNames': ['transcatheter arterial chemoembolization'], 'description': 'Trance-arterial chemotherapy', 'armGroupLabels': ['Favorable outcome', 'Unfavorable outcome']}, {'name': 'Liver resection', 'type': 'PROCEDURE', 'description': 'non-anatomical or anatomical liver resection', 'armGroupLabels': ['Favorable outcome']}, {'name': 'Combined radiofrequency ablation + percutaneous ethanol injection', 'type': 'COMBINATION_PRODUCT', 'description': 'combined therapy', 'armGroupLabels': ['Favorable outcome', 'Unfavorable outcome']}, {'name': 'Percutaneous ethanol injection', 'type': 'DRUG', 'otherNames': ['ETHANOL'], 'description': 'Percutaneous ethanol injection of HCC', 'armGroupLabels': ['Favorable outcome', 'Unfavorable outcome']}, {'name': 'Systemic chemotherapy', 'type': 'DRUG', 'otherNames': ['MIXED'], 'description': 'Systemic chemotherapy', 'armGroupLabels': ['Unfavorable outcome']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['NEXAVAR'], 'description': 'Sorafenib', 'armGroupLabels': ['Unfavorable outcome']}, {'name': 'Viscum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Viscum for HCC', 'armGroupLabels': ['Unfavorable outcome']}, {'name': 'Symptomatic treatment', 'type': 'DRUG', 'otherNames': ['SUPPORTIVE'], 'description': 'Symptomatic treatment', 'armGroupLabels': ['Unfavorable outcome']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emad A. Ahmed, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Emad Ali Ahmed Ali', 'investigatorAffiliation': 'Sohag University'}}}}