Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT06244966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GUM Remote Testing v4.0
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-15', 'releaseDate': '2025-07-30'}], 'estimatedResultsFirstSubmitDate': '2025-07-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Comparative study of two collection methods for blood samples'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative capillary and venous samples screening testing', 'timeFrame': '1 year', 'description': 'To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using the Roche Cobas e601 platform'}], 'secondaryOutcomes': [{'measure': 'Comparative capillary and venous samples confirmatory testing', 'timeFrame': '1 year', 'description': 'To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using other platforms and for viral load'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'Syphilis Infection', 'Hepatitis B and Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Capillary blood sample results are compared to venous blood results', 'detailedDescription': 'Capillary blood samples can be taken by patients from their own finger without requiring a healthcare professional to take a blood sample. Samples taken this way can be posted from home. This crucially avoids visits to the clinic or hospital to have blood samples taken. It would reduce the burden on healthcare professionals and is often preferred by patients. It is important to demonstrate that the results of an analysis performed on capillary blood samples are equivalent to the analysis of a standard venous sample.\n\nThis study aims to collect, in parallel to a standard venous blood sample, a capillary blood sample taken by the participant which is then added to specially designed filter paper (dried plasma spot sample) or other collection devices. Parallel analysis of paired samples will then allow the investigators to assess if results measured in samples taken using the two methods are similar.\n\nThe investigators will recruit 40 participants for each collection device to this study. It is important to obtain a range of positive and negative results from the study participants, and from stored samples and quality control material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* Able and willing to provide informed consent.\n* Already having a venous blood sample for clinical care\n\nExclusion Criteria:\n\n* Failure to consent'}, 'identificationModule': {'nctId': 'NCT06244966', 'briefTitle': 'GUM Remote Testing v4.0', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses', 'orgStudyIdInfo': {'id': '2312510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Any client attending clinic for venous blood sampling', 'description': 'Any client attending clinic for venous blood sampling for sexually transmitted disease diagnostics will also collect capillary blood using a finger prick', 'interventionNames': ['Diagnostic Test: HIV diagnostic testing']}], 'interventions': [{'name': 'HIV diagnostic testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Syphilis diagnostic testing', 'Hepatitis diagnostic testing'], 'description': 'Finger-prick capillary blood will be tested alongside venous blood', 'armGroupLabels': ['Any client attending clinic for venous blood sampling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX2 5AD', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'contacts': [{'name': 'Alison Kerridge', 'role': 'CONTACT', 'email': 'rduh.research-eastern@nhs.net', 'phone': '01392403055'}, {'name': 'Cressida Auckland', 'role': 'CONTACT', 'email': 'cressida.auckland@nhs.net', 'phone': '01392406459'}, {'name': 'Cressida Auckland', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Devon University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'centralContacts': [{'name': 'Cressida Auckland', 'role': 'CONTACT', 'email': 'cressida.auckland@nhs.net', 'phone': '01392 406459'}, {'name': 'Alison Kerridge', 'role': 'CONTACT', 'email': 'rduh.research-eastern@nhs.net', 'phone': '01392 403055'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-30', 'type': 'RELEASE'}, {'date': '2025-08-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Royal Devon and Exeter NHS Foundation Trust'}}}}