Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00889902
Status:
UNKNOWN
Last Update Posted:
2009-04-29
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis
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 exfoliated cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-27', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Molecular Markers', 'Cervical Cancer', 'Screening', 'Makov'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.\n2. reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.', 'detailedDescription': '1. To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.\n2. Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'residents of a certain town', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Married women aged 25 to 65-year-old with risk factors\n* No tumor and pelvic radiation therapy history\n* Non-pregnant women at present'}, 'identificationModule': {'nctId': 'NCT00889902', 'briefTitle': 'Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan University'}, 'officialTitle': 'Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis', 'orgStudyIdInfo': {'id': '320.6740'}}, 'contactsLocationsModule': {'locations': [{'city': 'Wufeng County', 'state': 'Hubei', 'country': 'China', 'facility': "People'S Hospital"}], 'centralContacts': [{'name': 'Hong B Cai, Doctor', 'role': 'CONTACT', 'email': 'Chb2105@163.com', 'phone': '0086-027-67813044'}, {'name': 'Ying J Huang', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Hong B Cai, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'gynecologic oncology department, Zhongnan Hospital of Wuhan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'HB Cai', 'oldOrganization': 'Wuhan University'}}}}