Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06213051
Status:
UNKNOWN
Last Update Posted:
2024-07-29
First Post:
2023-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1306}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR on health care provider-collected cervical samples as the reference standard.', 'timeFrame': '6 Months', 'description': 'Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA using PCR as the reference standard.'}], 'secondaryOutcomes': [{'measure': 'Compare the performance of self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.', 'timeFrame': '6 Months', 'description': 'Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal dry swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.'}, {'measure': 'Compare the performance of self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.', 'timeFrame': '6 Months', 'description': 'Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected vaginal wet swabs to provider-collected cervical samples for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.'}, {'measure': 'Compare the performance of self-collected vaginal dry swabs to self-collected vaginal wet swabs for detection of hrHPV DNA to screen for CIN2+ lesions using LBC as the reference standard.', 'timeFrame': '6 Months', 'description': 'Relative sensitivity and specificity, along with the percentage difference (with 95% confidence intervals), to compare self-collected dry swabs to self-collected wet swabs for detection of hrHPV to screen for CIN2+ lesions using LBC on health care provider-collected cervical samples as the reference standard.'}, {'measure': 'Assess the acceptability of self-collection vs provider-collection methods for HPV testing amongst women and health care workers.', 'timeFrame': '6 Months', 'description': 'Assessment of survey responses using descriptive statistics.'}, {'measure': 'Assess the usability of self-collection amongst women and to assess the usability of self-collection using vaginal dry swabs compared to self-collection using vaginal wet swabs and provider collection methods for HPV testing amongst health care workers.', 'timeFrame': '6 Months', 'description': 'Assessment of survey responses using descriptive statistics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Papillomavirus Infection']}, 'descriptionModule': {'briefSummary': 'This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.', 'detailedDescription': 'Self-collected vaginal samples for high-risk human papillomavirus (hrHPV) DNA testing are a promising alternative cervical cancer screening method for women who are reluctant to undergo healthcare provider-collection of cervical samples. Transportation of self-collected vaginal samples using swabs stored in liquid media incur additional costs and might create testing barriers for women. Dry transport of samples has the advantage of lower cost and ease of handling. Evidence on comparisons between self-collected vaginal samples using the dry swab and those transported in liquid media is limited, particularly in low- and middle-income countries (LMICs). The effect of using dry swabs on HPV-DNA detection in LMICs needs to be determined.\n\nThis study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA using LBC and as reference standard.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are eligible to be included in the study only if all of the inclusion criteria and none of the exclusion criteria indicated below apply.\n\nProspective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.', 'genderDescription': 'Adult Females only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Inclusion criteria for participants screened and enrolled consecutively as they present at the clinical study site:\n\n* Sexually active adult females ≥30 years of age (≥25 years of age if HIV+) presenting for treatment at a facility with an abnormal cervical cancer screening result (abnormal cytology, visual inspection with acetic acid and/or colposcopy)\n* Able to understand scope of study\n* Able to provide written informed consent\n* Willing to provide all necessary samples\n\nExclusion Criteria:\n\n* Vaccinated for HPV\n* Pregnancy\n* Patient not willing or unable to provide the all three swab samples (self-collected dry and wet and HCW collected cervical swabs)'}, 'identificationModule': {'nctId': 'NCT06213051', 'acronym': 'HPV', 'briefTitle': 'Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Innovative New Diagnostics, Switzerland'}, 'officialTitle': 'Clinical Study to Compare the Performance of Self-collected Vaginal Samples Transported Dry to Those Transported Wet for Detection of hrHPV DNA.', 'orgStudyIdInfo': {'id': 'WH001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort of sexually active adult females with an abnormal cervical cancer screening result.', 'description': 'Multi-center, prospective, paired, comparative diagnostic accuracy study To compare the performance of self-collected vaginal samples transported dry to those transported wet for detection of hrHPV DNA.\n\nInterventions:\n\nCOPAN floq swab transported wet and dry evaluated on Roche COBAS and Cepheid Xpert HPV tests', 'interventionNames': ['Device: • COPAN Self-collection FLOQSwabs® (COPAN, Italy)']}], 'interventions': [{'name': '• COPAN Self-collection FLOQSwabs® (COPAN, Italy)', 'type': 'DEVICE', 'otherNames': ['COPAN Self-collection FLOQSwabs® (COPAN, Italy) with 5ml PreservCyt Solution (Hologic)'], 'description': 'COPAN swabs evaluated on Roche COBAS and Cepheid Xpert PCRs', 'armGroupLabels': ['Cohort of sexually active adult females with an abnormal cervical cancer screening result.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rita Szekely', 'role': 'CONTACT', 'email': 'rita.szekely@finddx.org', 'phone': '+41 22 749 29 32'}, {'name': 'Debashish Das', 'role': 'CONTACT', 'email': 'debashish.das@finddx.org', 'phone': '+447708561187'}], 'overallOfficials': [{'name': 'Angela Muriuki', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Foundation for Innovative New Diagnostics (FIND)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Innovative New Diagnostics, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}, {'name': 'Frere Hospital, East London, South Africa', 'class': 'UNKNOWN'}, {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}