Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 5:23 PM
Study NCT ID:
NCT01065233
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pangenomic Study During Alcoholic Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008104', 'term': 'Liver Cirrhosis, Alcoholic'}], 'ancestors': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '2 blood samples of 5ml for DNA extraction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2013-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Existence of HCC and Pangenomic analysis of DNA polymorphism', 'description': 'Existence of HCC and determination of which genetic polymorphism are predisposing to HCC or preventing for HCC'}], 'secondaryOutcomes': [{'measure': 'cirrhosis severity (compensated or not)', 'description': 'Analysis of the genetic polymorphism involved in the severity of cirrhosis'}]}, 'conditionsModule': {'conditions': ['Alcoholic Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '25522809', 'type': 'DERIVED', 'citation': 'Archambeaud I, Auble H, Nahon P, Planche L, Fallot G, Faroux R, Gournay J, Samuel D, Kury S, Feray C. Risk factors for hepatocellular carcinoma in Caucasian patients with non-viral cirrhosis: the importance of prior obesity. Liver Int. 2015 Jul;35(7):1872-6. doi: 10.1111/liv.12767. Epub 2015 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.\n\nThe determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.\n\nIn this study, the investigators will identify predictives genetic polymorphism of HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '2 groups with 2 subgroups:\n\n* patient with HCC\n* HCC with Child A\n* HCC with Child B/C\n* patient without HCC\n* Child A without HCC\n* Child B/C without HCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 35 to 70 years old\n* Compensated cirrhosis or not\n* Caucasian origin of the parents\n* Patient with cirrhosis (histological proof or obvious)\n\nExclusion Criteria:\n\n* HIV, HBV, HCV positive\n* Known Homozygotia (C282Y+/+)\n* Important hepatocytary iron overload for patient with resection\n* HCC non histologically prooved'}, 'identificationModule': {'nctId': 'NCT01065233', 'acronym': 'CDCHC', 'briefTitle': 'Pangenomic Study During Alcoholic Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis', 'orgStudyIdInfo': {'id': 'BRD/07/08-M'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'alcoholic cirrhosis with viral infection', 'description': 'patient with alcoholic cirrhosis with viral infection (300 patients)', 'interventionNames': ['Genetic: DNA extraction']}, {'label': 'alcoholic cirrhosis without viral infection', 'description': 'patient with alcoholic cirrhosis without viral infection', 'interventionNames': ['Genetic: DNA extraction']}], 'interventions': [{'name': 'DNA extraction', 'type': 'GENETIC', 'description': 'DNA extraction of blood sample for DNAship analysis', 'armGroupLabels': ['alcoholic cirrhosis with viral infection', 'alcoholic cirrhosis without viral infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes UH', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Jean Verdier UH', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Paul Brousse UH', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes UH', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}