Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT03602703
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2018-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056486', 'term': 'Chemical and Drug Induced Liver Injury'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011041', 'term': 'Poisoning'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern of immunity in patients with de novo HCC develped after treatment with DAAs', 'timeFrame': 'Two months', 'description': 'Difference of B and T cells immune responses after treatment with DAAs between those who develop HCC and those who do not develop HCC'}]}, 'conditionsModule': {'keywords': ['Direct acting antiviral drugs immune responses'], 'conditions': ['Drug-Induced Liver Injury']}, 'descriptionModule': {'briefSummary': 'Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC', 'detailedDescription': 'Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.\n\nRadiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.\n\nBlood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.\n\nPeripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.\n\nB and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.\n\nCell cycle analysis and apoptosis will be detected using Annexin V/PI staining method and flow cytometry analysis. The phosphorylation and activation of cytoplasmic proteins will be tested using Western blot analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cases recruited divided into three groups .Each group either treated or not with DAAs', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with HCC on top of HCV related liver cirrhosis either received treatment or not\n* Patients without HCC either received treatment or not .\n* Patients with chronic HCV as a control group either received treatment or not.\n\nExclusion Criteria:\n\n* Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc\n* Patients with recurrent HCC after curative treatment.'}, 'identificationModule': {'nctId': 'NCT03602703', 'briefTitle': 'Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)', 'orgStudyIdInfo': {'id': '17300211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic HCV', 'description': 'chronic HCV either treated or not with DAAs.Flow cytometry and Western Blot analysis for each subgroup', 'interventionNames': ['Diagnostic Test: Flow cytometry and Western Blot analysis']}, {'label': 'Liver cirrhosis without HCC', 'description': 'Liver cirrhosis without HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup', 'interventionNames': ['Diagnostic Test: Flow cytometry and Western Blot analysis']}, {'label': 'Liver cirrhosis with HCC', 'description': 'Liver cirrhosis with HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup', 'interventionNames': ['Diagnostic Test: Flow cytometry and Western Blot analysis']}, {'label': 'Control group', 'description': 'Healthy subjects'}], 'interventions': [{'name': 'Flow cytometry and Western Blot analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic tests', 'armGroupLabels': ['Liver cirrhosis with HCC', 'Liver cirrhosis without HCC', 'chronic HCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7771', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Haidi Ramadan, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Haidi Karam', 'investigatorAffiliation': 'Assiut University'}}}}