Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-04 @ 4:26 AM
Study NCT ID:
NCT00266266
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2005-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Papilloma Virus DNA Self-Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2005-12-15', 'studyFirstSubmitQcDate': '2005-12-15', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV DNA self-testing device to detect disease in patients with abnormal Pap smear', 'timeFrame': 'Patient will self-test immediately prior to their standard physician papsmear', 'description': 'To assess the concordance of HPV DNA self-testing device to detect disease in patients with abnormal Pap smear. Patients with a positive HPV Self-test by vaginal swab or vaginal tampon will be compared to the physician test results for concordance. Following patient self-sample collection, physician will collect cervical samples using a spatula. A self testing device which patients can use at their convenience will be beneficial in decreasing the incidence of cervical cancer in Kentucky.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Papilloma Virus'], 'conditions': ['Papilloma Virus, Human']}, 'descriptionModule': {'briefSummary': 'HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?', 'detailedDescription': "Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Abnormal pap smear ASCUS or higher\n\nAge 18-postmenopausal', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAbnormal pap smear ASCUS or higher\n\nAge 18-postmenopausal\n\nExclusion Criteria:\n\nLess than 18 years old\n\nPrior hysterectomy\n\nPregnancy\n\nUse of corticosteroids\n\nHIV positive'}, 'identificationModule': {'nctId': 'NCT00266266', 'acronym': 'HPV', 'briefTitle': 'Human Papilloma Virus DNA Self-Test', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Human Papilloma Virus DNA Self-Test', 'orgStudyIdInfo': {'id': '529.03'}}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Robert Edwards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville,James Graham Brown Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'James Graham Brown Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}