Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-01-22 @ 1:25 AM
Study NCT ID:
NCT03772002
Status:
UNKNOWN
Last Update Posted:
2018-12-13
First Post:
2018-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2018-12-09', 'studyFirstSubmitQcDate': '2018-12-09', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.', 'timeFrame': '1 years'}, {'measure': 'The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.', 'timeFrame': '1 years'}, {'measure': 'The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.', 'timeFrame': '1 years'}], 'secondaryOutcomes': [{'measure': 'The percentage of CHC patients linked to care in non-infectious departments.', 'timeFrame': '1 years'}, {'measure': 'The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.', 'timeFrame': '1 years'}, {'measure': 'The referral rate of identified HCV infected patients.', 'timeFrame': '1 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of people with chronic hepatitis C (CHC) infection knowing their status. The major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. In the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the identification of inpatients who are unaware of HCV infection. However, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly low. A recent study from a major hospital in Jilin province of China showed that 3.36% of inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further performed in this study.\n\nFrom the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the infectious department in Chinese hospitals are relative independent from non-ID departments, meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians. Therefore, an appropriate clinical pathway for integration and linkage of non-ID department and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The investigator aim to establish a feasible clinical pathway and consensus guideline to enhance HCV testing surveillance with linkage to care in non-ID departments. Moreover, the participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRetrospective cohort:\n\n1. ≥ 18 years of age.\n2. Inpatients from non-infectious department.\n3. Documentation of laboratory test indicating positive HCV antibody.\n\nProspective cohort:\n\n1. ≥ 18 years of age.\n2. Inpatients from non-infectious departments.\n3. Patients who meet the requirement of HCV antibody screening:\n\n 1. patients with high risk possibility of HCV infection.\n 2. patients who will have special or invasive medical operation.\n 3. patients with unexplained abnormal liver biochemical laboratory results.\n\nExclusion Criteria:\n\nRetrospective cohort: Duplicated subjects.\n\nProspective cohort：Inability or unwillingness to provide informed consent or abide by the requirements of the study.'}, 'identificationModule': {'nctId': 'NCT03772002', 'briefTitle': 'Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Hepatitis C Surveillance With Linkage to Care of Patients From Non-infectious Departments in Tertiary Hospitals From Jiangsu, China', 'orgStudyIdInfo': {'id': 'IN-CN-987-5343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCV screening', 'interventionNames': ['Diagnostic Test: HCV screening']}], 'interventions': [{'name': 'HCV screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment', 'armGroupLabels': ['HCV screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213001', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Longgen Liu', 'role': 'CONTACT'}], 'facility': 'The Third Hospital of Changzhou', 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Chao Wu, M.D, Ph.D', 'role': 'CONTACT', 'email': 'dr.wu@nju.edu.cn', 'phone': '86-25-83105890'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Chao Wu, M.D, Ph.D.', 'role': 'CONTACT', 'email': 'dr.wu@nju.edu.cn', 'phone': '86-25-83105890'}, {'name': 'Yuxin Chen, Ph.D.', 'role': 'CONTACT', 'email': 'yuxin_chen2015@163.com', 'phone': '86-25-83105890'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Chao Wu', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}