Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-31 @ 9:37 AM
Study NCT ID:
NCT06527495
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacogenetic Study of Sorafenib in Egyptian 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': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2024-07-13', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular Endothelial Growth Factor A (VEGFA) genotyping', 'timeFrame': 'At Baseline, 3 month, and 6 month after treatment.', 'description': 'Genetic polymorphism of VEGFA'}, {'measure': 'Kinase insert domain receptor (KDR) genotyping', 'timeFrame': 'At Baseline, 3 month, and 6 months after treatment.', 'description': 'Genetic polymorphism of KDR'}], 'secondaryOutcomes': [{'measure': 'Tumor markers', 'timeFrame': 'At Baseline, 3 month, and 6 month after treatment.', 'description': 'Determination of serum Alpha-Fetoprotein, AFP-L3'}, {'measure': 'Complete blood culture', 'timeFrame': 'At Baseline 3 month, and 6 months after treatment.', 'description': 'Determination of hemoglobin concentration'}, {'measure': 'Kidney function tests', 'timeFrame': 'At Baseline 3 month, and 6 months after treatment.', 'description': 'Determination of Serum creatinine concentration'}, {'measure': 'Liver function tests.', 'timeFrame': 'At Baseline 3 month, and 6 months after treatment.', 'description': 'Determine serum level of ALT and AST'}, {'measure': 'Safety outcome', 'timeFrame': 'At Baseline, 3 month, and 6 months after treatment.', 'description': 'Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting, hand and foot syndrome)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of all studied subjects ≥ 18 years old\n* All patients with hepatocellular carcinoma will be included in group I.\n* Patients not treated with systemic TKIs\n\nExclusion Criteria:\n\n* Patients presented with liver tumors other than HCC.\n* Patients with Child-Pugh grade C for liver function.\n* Patients with other malignancies.\n* Patients with chronic inflammatory disorders.\n* Patients with severe organ dysfunction such as heart, lung, and kidney.\n* Patients who cannot tolerate or are allergic to sorafenib.\n* Patients with severe coagulation dysfunction were uncorrectable.\n* Age less than 18 years old.'}, 'identificationModule': {'nctId': 'NCT06527495', 'briefTitle': 'Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Clinical Pharmacogenetic Study of the Efficacy and Safety of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '00470/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorafenib', 'description': 'Sorafenib 200 - 400 mg twice daily', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Sorafenib Tablets (200 -400 mg) twice daily', 'armGroupLabels': ['Sorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Imam Waked', 'role': 'CONTACT', 'email': 'iwaked@liver-eg.org'}], 'facility': 'NLI', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Mahmoud Nazih', 'role': 'CONTACT', 'email': 'Mahmoud.Nazih5698@pharm.aun.edu.eg', 'phone': '00201093859868'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mahmoud Nazih', 'investigatorAffiliation': 'Assiut University'}}}}