Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT04717856
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionaire to determine the satisfaction of the use of the GenXpert', 'timeFrame': 'baseline', 'description': '1\\. To determine how the caregiver and the client experience the use of the GenXpert and what place the device can have in primary care. a. A questionnaire to determine the satisfaction of the user and the person tested'}], 'secondaryOutcomes': [{'measure': 'The detection of HCV RNA', 'timeFrame': 'Baseline', 'description': 'a. One finger prick to measure the HCV RNA. These blood samples are processed directly using the HCV Viral Load fingerstick cartridge which is processed via the GenXpert device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Use', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The results of the GX device are equivalent to standard venous blood sampling. With this study we are going to determine the prevalence in drug users with difficult venous access. On the other hand, we want to look at the place this device can have in primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have recently or ever used drugs\n* Older than 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Not being able to speak the Dutch language'}, 'identificationModule': {'nctId': 'NCT04717856', 'briefTitle': 'Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA Using a Finger Prick; a Cross-sectional, Multicentre Study Among Drug Users', 'orgStudyIdInfo': {'id': 'CEPHEID-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'drug users', 'interventionNames': ['Other: screening: HCV RNA test and risk factors questionaire']}], 'interventions': [{'name': 'screening: HCV RNA test and risk factors questionaire', 'type': 'OTHER', 'description': 'Screening by using a rapid finger prick test for HCV RNA and a questionnaire to assess risk factors.', 'armGroupLabels': ['drug users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3590', 'city': 'Diepenbeek', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dana Busschots, drs.', 'role': 'CONTACT', 'email': 'dana.busschots@uhasselt.be', 'phone': '+32 89 21 20 61'}, {'name': 'Geert Robaeys, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dana Busschotes, drs.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hasselt University', 'geoPoint': {'lat': 50.90769, 'lon': 5.41875}}], 'centralContacts': [{'name': 'Geert Robaeys, prof. dr.', 'role': 'CONTACT', 'email': 'geert.robaeys@zol.be', 'phone': '+32 89 32 65 05'}, {'name': 'Dana Busschots, drs.', 'role': 'CONTACT', 'email': 'dana.busschots@uhasselt.be', 'phone': '+32 89 21 20 61'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Geert Robaeys', 'investigatorAffiliation': 'Hasselt University'}}}}