Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-20 @ 1:31 PM
Study NCT ID:
NCT04222803
Status:
SUSPENDED
Last Update Posted:
2025-04-09
First Post:
2020-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VIRal Hepatitis and GAllstone Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '9 mL serum will be sampled from each participant in the study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'The study is currently on hold owing to the introduction of a new electronic system at some of the participating hospitals.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease', 'timeFrame': '1 day', 'description': 'The proportion of patient with verified gallstone disease having detectable anti-HAV IgM, HBsAg, HCV Core antigen or HEV RNA will be compared with the proportion among patients without verified gallstone disease.'}, {'measure': 'Association between ongoing hepatitis A virus infection and ultrasound or computed tomography-verified gallstone disease', 'timeFrame': '1 day', 'description': 'The proportion of patient with verified gallstone disease having detectable anti-HAV IgM will be compared with the proportion among patients without verified gallstone disease.'}, {'measure': 'Association between ongoing hepatitis B virus infection and ultrasound or computed tomography-verified gallstone disease', 'timeFrame': '1 day', 'description': 'The proportion of patient with verified gallstone disease having detectable HBsAg will be compared with the proportion among patients without verified gallstone disease.'}, {'measure': 'Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease', 'timeFrame': '1 day', 'description': 'The proportion of patient with verified gallstone disease having detectable HCV Core antigen will be compared with the proportion among patients without verified gallstone disease.'}, {'measure': 'Association between ongoing hepatitis E virus infection and ultrasound or computed tomography-verified gallstone disease', 'timeFrame': '1 day', 'description': 'The proportion of patient with verified gallstone disease having detectable HEV RNA will be compared with the proportion among patients without verified gallstone disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gallstone Attack', 'Viral Hepatitis']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.', 'detailedDescription': 'Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with and without ultrasound or computed tomography-verified gallstone disease will be compared for biomarkers of ongoing viral hepatitis (i.e. anti-HAV IgM, HBsAg, HCV Core antigen and HEV RNA).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg\n* Written informed consent\n* Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA\n\nExclusion Criteria:\n\n* Not willing to give written informed consent\n* Age below 18 years'}, 'identificationModule': {'nctId': 'NCT04222803', 'acronym': 'VIRGAD', 'briefTitle': 'VIRal Hepatitis and GAllstone Disease Study', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Viral Hepatitis and Gallstone Disease Study', 'orgStudyIdInfo': {'id': 'VIRGAD'}}, 'contactsLocationsModule': {'locations': [{'zip': '501 82', 'city': 'Borås', 'country': 'Sweden', 'facility': 'Södra Älvsborgs Sjukhus', 'geoPoint': {'lat': 57.72101, 'lon': 12.9401}}], 'overallOfficials': [{'name': 'Martin Martin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martin Lagging, MD PhD', 'investigatorAffiliation': 'Göteborg University'}}}}