Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 3:27 AM
Study NCT ID:
NCT00902551
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2009-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Cytometry for Cervical Cancer Screening in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cervical samples were taken through cervical brush. Feulgen method is used to determine the amount of DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-09', 'studyFirstSubmitDate': '2009-05-14', 'studyFirstSubmitQcDate': '2009-05-14', 'lastUpdatePostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of cervical cancer.', 'timeFrame': 'From the testing performed by the investigator (0h) to one year follow-up period'}], 'secondaryOutcomes': [{'measure': 'The rate of death.', 'timeFrame': 'One year follow-up period after screening.'}, {'measure': 'The incidence of cervical intraepithelial neoplasia.', 'timeFrame': 'From the screening (0h) to one year follow-up period'}, {'measure': 'Cervical inflammation', 'timeFrame': 'From the screening (0h) to one year follow-up period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['DNA cytometry', 'Cytology', 'Diagnosis accuracy'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '19825960', 'type': 'RESULT', 'citation': 'Tong H, Shen R, Wang Z, Kan Y, Wang Y, Li F, Wang F, Yang J, Guo X; Mass Cervical Cancer Screening Regimen Group. DNA ploidy cytometry testing for cervical cancer screening in China (DNACIC Trial): a prospective randomized, controlled trial. Clin Cancer Res. 2009 Oct 15;15(20):6438-45. doi: 10.1158/1078-0432.CCR-09-1689. Epub 2009 Oct 13.'}]}, 'descriptionModule': {'briefSummary': "Very few screenings of any kind will be possible during a woman's lifetime in most low-resource regions, where 80% of the half-million global cases of cervical cancer occur every year. Although a single round of human papillomavirus (HPV) testing was associated with a significant decline in the rate of advanced cervical cancers and associated deaths, whether other methods like as DNA image cytometry can be used as an more accurate means than others in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both DNA image cytometry and conventional cytology is not well known. The investigators hypothesized that DNA image cytometry was superior in screening cervical cancer than conventional cytology."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently or had been married\n* Not pregnant\n* Had an intact uterus with no prolapse\n* Had no history of cervical cancer\n* Living in China\n\nExclusion Criteria:\n\n* Not willing to participate or finish the study at any time\n* History of cervical surgeries'}, 'identificationModule': {'nctId': 'NCT00902551', 'acronym': 'DNACIC', 'briefTitle': 'DNA Cytometry for Cervical Cancer Screening in China', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Comparison of DNA Image Cytometry and Conventional Cytology for Cervical Cancer Screening in China', 'orgStudyIdInfo': {'id': 'NMU-200703-FC012'}, 'secondaryIdInfos': [{'id': 'NJFY-2007-12901'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Subjects underwent cervical sample DNA image cytometry'}, {'label': '2', 'description': 'Subjects underwent cervical sample conventional cytology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'XiRong Guo', 'oldOrganization': 'Nanjing Medical University'}}}}