Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:29 AM
Study NCT ID:
NCT07404566
Status:
COMPLETED
Last Update Posted:
2026-02-12
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in Hepatitis C Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The study involved the collection of human blood samples, specifically processed into the following formats:\n\nSerum: Obtained by collecting blood in clean tubes, allowing it to clot, and centrifuging at 1000 rpm for 10 minutes.\n\nPlasma/Supernatant: Collected into EDTA-containing tubes and centrifuged to separate the supernatant.\n\nTotal RNA: Extracted from the blood samples, specifically including the microRNA fraction for PCR analysis.\n\nStorage and Laboratory Processing\n\nSerum Storage: Serum samples used for alpha-fetoprotein (AFP) ELISA estimation were kept frozen at -20 °C.\n\nRNA Storage: The supernatant for RNA extraction was stored in RNase-free tubes at -80 °C prior to the extraction process.\n\nMolecular Analysis: The retained specimens were used for reverse transcription of cDNA and subsequent Real-time RT-qPCR to determine the relative number of Mir copies using the ΔΔCT method.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma', 'timeFrame': 'Around 3 months', 'description': 'iagnostic utility (sensitivity, specificity, and accuracy rate) of estimated plasma expression (PE) levels of microRNAs (specifically Mir-1246, Mir-21, and Mir-497) to distinguish HCC from LC and HCV'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Performance for LC', 'timeFrame': 'Around 3 months', 'description': 'Differentiating liver cirrhosis using downregulated MiR-205 and overexpressed MiR-29a.'}, {'measure': 'Biomarker Correlation', 'timeFrame': 'Around 3 months', 'description': 'Correlation between miRNA levels and serum Alpha-Fetoprotein (AFP).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study evaluates a target population of patients with Hepatitis C virus (HCV) infection, including those with complications like liver cirrhosis (LC) and hepatocellular carcinoma (HCC), to investigate the diagnostic utility of a specific panel of microRNAs (miRNAs). The intervention involves quantifying the plasma expression (PE) levels of MiR-21, 1246, 205, 29a-3p, and 497 via PCR and comparing them to healthy controls to determine their efficacy as biomarkers. The primary outcome is to assess the sensitivity, specificity, and overall accuracy of these miRNAs in differentiating HCC from cirrhotic and non-cirrhotic HCV cases, aiming to establish more reliable screening tools than current standard biomarkers like alpha-fetoprotein (AFP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals attending outpatient clinics for new or chronic HCV follow-up, and healthy volunteers from blood banks, primarily located in Egypt.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed HCV infection.\n* Chronic uncomplicated HCV infection.\n* HCV complicated with liver cirrhosis.\n* HCV complicated with HCC on top of cirrhosis.\n* Willingness to participate and sign written informed consent.\n\nExclusion Criteria:\n\n* Advanced stage of hepatic cirrhosis with portal hypertension or hepatorenal failure.\n* Hepatic malignancies other than HCC.\n* Bilharzial pre-portal fibrosis.\n* Alcoholic fatty liver disease\n* hepatosteatosis.'}, 'identificationModule': {'nctId': 'NCT07404566', 'briefTitle': 'Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in Hepatitis C Patients', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'The Merits of Implementing microRNAs for Diagnosing Hepatocellular Carcinoma Among Hepatitis C Patients', 'orgStudyIdInfo': {'id': 'E/C.S/N.R15/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCV Group', 'description': '21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC.', 'interventionNames': ['Diagnostic Test: PCR']}, {'label': 'LC Group', 'description': '21 patients with HCV complicated by liver cirrhosis.', 'interventionNames': ['Diagnostic Test: PCR']}, {'label': 'HCC Group', 'description': '21 patients with HCV complicated by hepatocellular carcinoma.', 'interventionNames': ['Diagnostic Test: PCR']}, {'label': 'Control Group', 'description': '21 healthy volunteers who passed pre-donation investigations at a Blood Bank.', 'interventionNames': ['Diagnostic Test: PCR']}], 'interventions': [{'name': 'PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).', 'armGroupLabels': ['Control Group', 'HCC Group', 'HCV Group', 'LC Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21512', 'city': 'Alexandria', 'state': 'El Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant consultant of Clinical Pathology', 'investigatorFullName': 'Raafat R. Mohammed', 'investigatorAffiliation': 'Benha University'}}}}