Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT06631560
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatitis E Virus Infection in Oncological Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti HEV-IgM and IgG prevalences', 'timeFrame': 'In the oncological cohort, multiple samples were prospectively collected over a one-year period, commencing on 1 September 2020 and concluding at the end of October 2021. In the remaining two control samples, analysis was conducted retrospectively.', 'description': 'Anti-HEV prevalences were determined in each arm with two different assays'}], 'secondaryOutcomes': [{'measure': 'Identification of risk factors for HEV infection in oncological patients', 'timeFrame': 'The questionnaire was handed out at the beginning of the study', 'description': 'Oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection. Part of the questions were posed in a binary format, requiring a "yes" or "no" response. Additionally, we inquired as to the frequency with which risk factors such as pork are consumed. A multiple-choice format was employed, with the majority of questions comprising single-select multiple-choice options. To illustrate, the question for example enquired as to the frequency with which the patient consumed raw or undercooked pork products. The options ranged from "never" to "more than once a month".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis E Infection', 'Hepatitis; Epidemic', 'Oncologic Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each patient before treatment initiation and during treatment follow-up. Primary endpoint was determination of HEV seroprevalence. A healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of SARS-CoV-2 infection. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* different hemato-oncological entities without age restriction\n\nExclusion Criteria:\n\n* patients already receiving antineoplastic therapies\n* not given written consent'}, 'identificationModule': {'nctId': 'NCT06631560', 'acronym': 'HepE-Onko-BB', 'briefTitle': 'Hepatitis E Virus Infection in Oncological Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medizinische Hochschule Brandenburg Theodor Fontane'}, 'officialTitle': 'Hepatitis E Virus Infection in Oncological Patients - a Prospective Study in Rural Eastern Germany', 'orgStudyIdInfo': {'id': 'HepE-Onko-BB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oncological disease', 'description': 'Serum was taken from each patient before treatment initiation and during treatment follow-up. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.', 'interventionNames': ['Diagnostic Test: ELISA testing']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy controls', 'description': 'Serum samples were analysed retrospectively using HEV ELISAs', 'interventionNames': ['Diagnostic Test: ELISA testing']}, {'type': 'EXPERIMENTAL', 'label': 'Control hospitalized due to SARS-CoV-2 infection', 'description': 'Serum samples were analysed retrospectively using HEV ELISAs', 'interventionNames': ['Diagnostic Test: ELISA testing']}], 'interventions': [{'name': 'ELISA testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.', 'armGroupLabels': ['Control hospitalized due to SARS-CoV-2 infection', 'Healthy controls', 'Oncological disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14776', 'city': 'Brandenburg', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Medical School (MHB) Theodor Fontane', 'geoPoint': {'lat': 52.41667, 'lon': 12.55}}], 'overallOfficials': [{'name': 'Isabel-Elena Haller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School (MHB) Theodor Fontane'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medizinische Hochschule Brandenburg Theodor Fontane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Isabel-Elena Haller', 'investigatorAffiliation': 'Medizinische Hochschule Brandenburg Theodor Fontane'}}}}