Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-04-23 @ 3:22 PM
Study NCT ID:
NCT02461966
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2015-05-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000348', 'term': 'Aflatoxins'}], 'ancestors': [{'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009183', 'term': 'Mycotoxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sherif_tropical@yahoo.com', 'phone': '00201095159522', 'title': 'Sherief Abd-Elsalam', 'organization': 'Tanta university'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': '0 means no side effects', 'eventGroups': [{'id': 'EG000', 'title': 'Hepatocellular Carcinoma (HCC)', 'description': 'Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)\n\nAflatoxin: Evaluation of Aflatoxin level', 'otherNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cirrhotic Patients', 'description': 'Estimation of serum aflatoxin level in 80 patients with liver cirrhosis\n\nAflatoxin: Evaluation of Aflatoxin level', 'otherNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study\n\nAflatoxin: Evaluation of Aflatoxin level', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Aflatoxin Level in Liver Cancer Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hepatocellular Carcinoma (HCC)', 'description': 'Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'OG001', 'title': '80 Cirrhotic Patients', 'description': 'Estimation of serum aflatoxin level in 80 patients with liver cirrhosis\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study\n\nAflatoxin: Evaluation of Aflatoxin level'}], 'classes': [{'categories': [{'measurements': [{'value': '7.96', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '6.10', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '4.13', 'spread': '1.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.', 'unitOfMeasure': 'ng\\ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hepatocellular Carcinoma (HCC)', 'description': 'Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'FG001', 'title': 'Cirrhotic Patients', 'description': 'Estimation of serum aflatoxin level in 80 patients with liver cirrhosis\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study\n\nAflatoxin: Evaluation of Aflatoxin level'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Hepatocellular Carcinoma (HCC)', 'description': 'Estimation of serum aflatoxin level in 160 patients with hepatocellular carcinoma (HCC)\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'BG001', 'title': 'Cirrhotic Patients', 'description': 'Estimation of serum aflatoxin level in 80 patients with liver cirrhosis\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Estimation of serum aflatoxin level in 60 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study\n\nAflatoxin: Evaluation of Aflatoxin level'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age, categorical numerical', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '58.58', 'spread': '9.58', 'groupId': 'BG000'}, {'value': '50.00', 'spread': '8.72', 'groupId': 'BG001'}, {'value': '27.80', 'spread': '5.06', 'groupId': 'BG002'}, {'value': '45', 'spread': '23.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No Masking'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-01', 'studyFirstSubmitDate': '2015-05-31', 'resultsFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-12', 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Aflatoxin Level in Liver Cancer Patients', 'timeFrame': '6 months', 'description': 'Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend of risk factors differs in different parts of the world, and this may explain in part the diverse biologic characteristics of HCC in different populations .\n\nExposure to aflatoxin is an additional risk factor for the development of HCC, through damage of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed that aflatoxin B1 has a considerable role in the development of HCC among Egyptians .\n\nClinical studies have shown that AFB1 selectively targets at the third base position of codon 249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC) . A significant association between aflatoxin exposure and HCC has been reported in hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B (HBV) infection on HCC risk has been reported in several epidemiologic studies.\n\nAflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV) patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic hepatic parenchyma scores in anti-HCV-positive subjects .', 'detailedDescription': 'Hepatocellular carcinoma (HCC) is the fifth most common malignancy in the world and the third most common cause of cancer-related deaths complicating liver cirrhosis in most cases.\n\nIn Egypt, there has been a remarkable increase of the proportion of HCC among chronic liver diseases (CLD) patients from 4.0% to 7.2% over a decade. This rising proportion may be explained by the increasing risk factors such as the emergence of hepatitis C virus (HCV) over the same period of time, the contribution of hepatitis B virus (HBV) infection, improvement of the screening programs and diagnostic tools of HCC as well as the increased survival rate among patients with cirrhosis to allow time for some of them to develop HCC .\n\nHepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend of risk factors differs in different parts of the world, and this may explain in part the diverse biologic characteristics of HCC in different populations .\n\nExposure to aflatoxin is an additional risk factor for the development of HCC, through damage of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed that aflatoxin B1 has a considerable role in the development of HCC among Egyptians .\n\nClinical studies have shown that AFB1 selectively targets at the third base position of codon 249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC) . A significant association between aflatoxin exposure and HCC has been reported in hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B (HBV) infection on HCC risk has been reported in several epidemiologic studies.\n\nAflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV) patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic hepatic parenchyma scores in anti-HCV-positive subjects .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cirrhotic patient with and without HCC\n\nExclusion Criteria:\n\n* Malignancy other than HCC'}, 'identificationModule': {'nctId': 'NCT02461966', 'briefTitle': 'Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Evaluation of the Role of Aflatoxin as an Environmental Risk Factor Attributable to Liver Cancer in Nile Delta', 'orgStudyIdInfo': {'id': 'Aflatoxin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hepatocellular carcinoma (HCC)', 'description': 'Estimation of serum aflatoxin level in 40 patients with hepatocellular carcinoma (HCC)', 'interventionNames': ['Other: Aflatoxin']}, {'type': 'OTHER', 'label': '20 cirrhotic patients', 'description': 'Estimation of serum aflatoxin level in 20 patients with liver cirrhosis', 'interventionNames': ['Other: Aflatoxin']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Estimation of serum aflatoxin level in 15 individuals, as a control group in patient house whom share the same quality of life and whom were neither HCC patients nor cirrhotic patients, were invited to share in the study', 'interventionNames': ['Other: Aflatoxin']}], 'interventions': [{'name': 'Aflatoxin', 'type': 'OTHER', 'description': 'Evaluation of Aflatoxin level', 'armGroupLabels': ['20 cirrhotic patients', 'Control group', 'Hepatocellular carcinoma (HCC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Elgharbia', 'country': 'Egypt', 'facility': 'Tanta university - faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Sharaf-eldin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'hepatology dept-Tanta'}, {'name': 'Raafat Salah, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'hepatology dept-Tanta'}, {'name': 'hanan Soliman, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'hepatology dept-Tanta'}, {'name': 'Sherief abd-elsalm, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'hepatology dept-Tanta'}, {'name': 'Walaa Elkhalawany, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'hepatology dept-Tanta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'sponsor investigator', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}