Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT04208035
Status:
UNKNOWN
Last Update Posted:
2019-12-23
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatitis C Elimination in the Netherlands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-20', 'releaseDate': '2024-04-11'}, {'resetDate': '2024-11-22', 'releaseDate': '2024-10-01'}], 'estimatedResultsFirstSubmitDate': '2024-04-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of lost to follow-up (LTFU) patients successfully re-linked to care', 'timeFrame': 'End of study, on average 2.5 years after initiation'}], 'secondaryOutcomes': [{'measure': 'Total number of LTFU patients in the investigated time period', 'timeFrame': '15 years prior to study initiation'}, {'measure': 'Case ascertainment rate', 'timeFrame': 'End of study, on average 2.5 years after initiation', 'description': 'Established contact (via telephone or in writing) with a patient who is eligible for retrieval'}, {'measure': 'Awareness of HCV diagnosis among LTFU patients', 'timeFrame': 'End of study, on average 2.5 years after initiation', 'description': 'Number of patients who were aware of their HCV diagnosis when they are invited for re-evaluation'}, {'measure': 'Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test', 'timeFrame': 'End of study, on average 2.5 years after initiation'}, {'measure': 'Number of viraemic patients at time of re-evaluation', 'timeFrame': 'End of study, on average 2.5 years after initiation'}, {'measure': 'Liver fibrosis stage of retrieved patients', 'timeFrame': 'End of study, on average 2.5 years after initiation'}, {'measure': 'Reasons for becoming LTFU', 'timeFrame': 'End of study, on average 2.5 years after initiation'}, {'measure': 'Time of being LTFU', 'timeFrame': 'End of study, on average 2.5 years after initiation', 'description': 'Defined as years since last (HCV-)related hospital visit'}, {'measure': 'Mode of HCV transmission', 'timeFrame': 'End of study, on average 2.5 years after initiation'}, {'measure': 'Sustained virological response', 'timeFrame': 'End of study, on average 2.5 years after initiation', 'description': 'Defined as the absence of HCV RNA at least 12 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis c']}, 'referencesModule': {'references': [{'pmid': '32377367', 'type': 'DERIVED', 'citation': 'Isfordink CJ, Brakenhoff SM, van Dijk M, van der Valk M, de Knegt RJ, Arends JE, Drenth JP; HepNed study group. Hepatitis C elimination in the Netherlands (CELINE): study protocol for nationwide retrieval of lost to follow-up patients with chronic hepatitis C. BMJ Open Gastroenterol. 2020 Apr 12;7(1):e000396. doi: 10.1136/bmjgast-2020-000396. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lost to follow-up (possibly) chronically HCV-infected patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ever diagnosed with (possible) chronic HCV in the 15-year period prior to initiation of the study, defined as having had a positive anti-HCV or HCV RNA test\n* Lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive HCV test result\n\nExclusion Criteria:\n\n* Younger than 18\n* Deceased\n* Not residing in the Netherlands\n* Unknown current address\n* Severe comorbidity or short life expectancy that limits patients from benefiting from retrieval'}, 'identificationModule': {'nctId': 'NCT04208035', 'acronym': 'CELINE', 'briefTitle': 'Hepatitis C Elimination in the Netherlands', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients', 'orgStudyIdInfo': {'id': '2018-4503'}}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marleen van Dijk, MD', 'role': 'CONTACT', 'email': 'marleen.vandijk@radboudumc.nl', 'phone': '0031243613999'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Marleen van Dijk, MD', 'role': 'CONTACT', 'email': 'marleen.vandijk@radboudumc.nl', 'phone': '0034243613999'}], 'overallOfficials': [{'name': 'Joost Drenth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Joost Drenth', 'investigatorAffiliation': 'Radboud University Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-11', 'type': 'RELEASE'}, {'date': '2024-09-20', 'type': 'RESET'}, {'date': '2024-10-01', 'type': 'RELEASE'}, {'date': '2024-11-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Joost Drenth, Professor, MD, PhD, Radboud University Medical Center'}}}}