Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-26 @ 11:03 AM
Study NCT ID:
NCT00474968
Status:
COMPLETED
Last Update Posted:
2009-11-20
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rdomanik@cytocoreinc.com', 'phone': '312-222-9550', 'title': 'Richard Domanik, Ph.D.', 'organization': 'CytoCore, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SoftPAP', 'description': 'Samples collected using the SoftPAP Collector', 'otherNumAtRisk': 348, 'otherNumAffected': 0, 'seriousNumAtRisk': 348, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brush/Spatula', 'description': 'Samples collected using an endocervical brush and cervical spatula', 'otherNumAtRisk': 355, 'otherNumAffected': 0, 'seriousNumAtRisk': 355, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cell Collection Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftPAP', 'description': 'Samples collected using the SoftPAP Collector'}, {'id': 'OG001', 'title': 'Brush/Spatula', 'description': 'Samples collected using an endocervical brush and cervical spatula'}], 'classes': [{'title': 'True Positive (TP) (Cytology Dx vs (Bx + ECC)', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}, {'title': 'True Negative (TN) (Cytology Dx vs (Bx + ECC))', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'False Positive (FP) (Cytology Dx vs (Bx + ECC))', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'False Negative (FN) (Cytology Dx vs (Bx + ECC))', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Excluded - Bx/ECC results not reported', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of cell collection.', 'description': 'True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported'}, {'type': 'SECONDARY', 'title': 'Human Papilloma Virus (HPV) Detection Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftPAP', 'description': 'Samples collected using the SoftPAP Collector'}, {'id': 'OG001', 'title': 'Brush/Spatula', 'description': 'Samples collected using an endocervical brush and cervical spatula'}], 'classes': [{'title': 'HPV Positive by Hybrid Capture-II', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'HPV Negative by Hybrid Capture-II', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Hybrid Capture-II Results Not Reported', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of cell collection.', 'description': 'Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Specimen Adequacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftPAP', 'description': 'Samples collected using the SoftPAP Collector'}, {'id': 'OG001', 'title': 'Brush/Spatula', 'description': 'Samples collected using an endocervical brush and cervical spatula'}], 'classes': [{'title': 'Satisfactory for Diagnosis', 'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}]}, {'title': 'Unsatisfactory for Diagnosis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Excluded - Slide Preparation Error', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of cell collection', 'description': 'Number and percentage of samples classified as adequate for diagnosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all cytology specimens'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SoftPAP', 'description': 'Samples collected using the SoftPAP Collector'}, {'id': 'FG001', 'title': 'Brush/Spatula', 'description': 'Samples collected using an endocervical brush and cervical spatula'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}, {'groupId': 'FG001', 'numSubjects': '371'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '348'}, {'groupId': 'FG001', 'numSubjects': '355'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Sample not collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients presenting for a previously scheduled colposcopy subsequent to an abnormal Pap result were recruited for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '737', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SoftPAP', 'description': 'Samples collected using the SoftPAP Collector'}, {'id': 'BG001', 'title': 'Brush/Spatula', 'description': 'Samples collected using an endocervical brush and cervical spatula'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '731', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '737', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '737', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Cervical cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 737}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-16', 'studyFirstSubmitDate': '2007-05-16', 'resultsFirstSubmitDate': '2009-05-04', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-29', 'studyFirstPostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell Collection Efficacy', 'timeFrame': 'At the time of cell collection.', 'description': 'True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.'}, {'measure': 'Specimen Adequacy', 'timeFrame': 'At time of cell collection', 'description': 'Number and percentage of samples classified as adequate for diagnosis'}], 'secondaryOutcomes': [{'measure': 'Human Papilloma Virus (HPV) Detection Frequency', 'timeFrame': 'At the time of cell collection.', 'description': 'Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colposcopy', 'Biopsy']}, 'referencesModule': {'references': [{'pmid': '12571259', 'type': 'BACKGROUND', 'citation': 'Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641.'}, {'pmid': '11693978', 'type': 'BACKGROUND', 'citation': 'Sankaranarayanan R, Budukh AM, Rajkumar R. Effective screening programmes for cervical cancer in low- and middle-income developing countries. Bull World Health Organ. 2001;79(10):954-62. Epub 2001 Nov 1.'}, {'pmid': '15725861', 'type': 'BACKGROUND', 'citation': 'Waxman AG. Guidelines for cervical cancer screening: history and scientific rationale. Clin Obstet Gynecol. 2005 Mar;48(1):77-97. doi: 10.1097/01.grf.0000151590.08451.26. No abstract available.'}, {'pmid': '10451450', 'type': 'BACKGROUND', 'citation': 'Holowaty P, Miller AB, Rohan T, To T. RESPONSE: re: natural history of dysplasia of the uterine cervix. J Natl Cancer Inst. 1999 Aug 18;91(16):1420A-1421. doi: 10.1093/jnci/91.16.1420a. No abstract available.'}, {'pmid': '11966386', 'type': 'BACKGROUND', 'citation': "Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. doi: 10.1001/jama.287.16.2114."}, {'pmid': '10819705', 'type': 'BACKGROUND', 'citation': 'Nanda K, McCrory DC, Myers ER, Bastian LA, Hasselblad V, Hickey JD, Matchar DB. Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med. 2000 May 16;132(10):810-9. doi: 10.7326/0003-4819-132-10-200005160-00009.'}, {'pmid': '7702044', 'type': 'BACKGROUND', 'citation': 'Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol. 1995 Apr 1;141(7):680-9. doi: 10.1093/oxfordjournals.aje.a117485.'}, {'pmid': '11401314', 'type': 'BACKGROUND', 'citation': 'Clavel C, Masure M, Bory JP, Putaud I, Mangeonjean C, Lorenzato M, Nazeyrollas P, Gabriel R, Quereux C, Birembaut P. Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions: a study of 7932 women. Br J Cancer. 2001 Jun 15;84(12):1616-23. doi: 10.1054/bjoc.2001.1845.'}, {'pmid': '15774236', 'type': 'BACKGROUND', 'citation': 'Willis BH, Barton P, Pearmain P, Bryan S, Hyde C. Cervical screening programmes: can automation help? Evidence from systematic reviews, an economic analysis and a simulation modelling exercise applied to the UK. Health Technol Assess. 2005 Mar;9(13):1-207, iii. doi: 10.3310/hta9130.'}, {'pmid': '8942687', 'type': 'BACKGROUND', 'citation': 'Buntinx F, Brouwers M. Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies. BMJ. 1996 Nov 23;313(7068):1285-90. doi: 10.1136/bmj.313.7068.1285.'}, {'pmid': '10577637', 'type': 'BACKGROUND', 'citation': 'Martin-Hirsch P, Lilford R, Jarvis G, Kitchener HC. Efficacy of cervical-smear collection devices: a systematic review and meta-analysis. Lancet. 1999 Nov 20;354(9192):1763-70. doi: 10.1016/s0140-6736(99)02353-3.'}, {'pmid': '10796736', 'type': 'BACKGROUND', 'citation': 'Martin-Hirsch P, Jarvis G, Kitchener H, Lilford R. Collection devices for obtaining cervical cytology samples. Cochrane Database Syst Rev. 2000;2000(2):CD001036. doi: 10.1002/14651858.CD001036.'}, {'pmid': '10907927', 'type': 'BACKGROUND', 'citation': 'Selvaggi SM, Guidos BJ. Specimen adequacy and the ThinPrep Pap Test: the endocervical component. Diagn Cytopathol. 2000 Jul;23(1):23-6. doi: 10.1002/1097-0339(200007)23:13.0.CO;2-K.'}, {'pmid': '16218317', 'type': 'BACKGROUND', 'citation': 'Marchand L, Mundt M, Klein G, Agarwal SC. Optimal collection technique and devices for a quality pap smear. WMJ. 2005 Aug;104(6):51-5.'}, {'pmid': '11214608', 'type': 'BACKGROUND', 'citation': 'Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer.\n\nThe InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector', 'detailedDescription': 'The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women \\> 18 years of age with an abnormal pap within 30 days to 1 year for whom a colposcopy is scheduled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ages 18 years old and above\n* Women scheduled to undergo colposcopy\n\nExclusion Criteria:\n\n* Patients who have had a hysterectomy\n* Patients who are pregnant.'}, 'identificationModule': {'nctId': 'NCT00474968', 'briefTitle': 'Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytoCore, Inc.'}, 'officialTitle': 'Clinical Study Validating the Adequacy, Efficacy, and Safety of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique In Patients With Recent History of Abnormal Pap Test Returning for Colposcopy/Biopsy.', 'orgStudyIdInfo': {'id': 'e2TM Cervical cell Collector'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1 - Experimental', 'description': 'e2 Cell Collector \\[SoftPAP(R)\\]', 'interventionNames': ['Device: e2 Cell Collector [SoftPAP(R)]']}, {'label': 'Arm 2 - Control', 'description': 'Brush/spatula', 'interventionNames': ['Device: Spatula/Brush']}], 'interventions': [{'name': 'e2 Cell Collector [SoftPAP(R)]', 'type': 'DEVICE', 'description': 'Cervical cells collected using the e2 Cell Collector \\[SoftPAP(R)\\]', 'armGroupLabels': ['Arm 1 - Experimental']}, {'name': 'Spatula/Brush', 'type': 'DEVICE', 'description': 'Cervical cells collected using a combination of a cervical spatula and an endocervical brush', 'armGroupLabels': ['Arm 2 - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Clinical Trials', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '63106', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Centers', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75246', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Jay S. Pinkerton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytoCore, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Richard Domanik', 'oldOrganization': 'CytoCore'}}}}