Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT01313104
Status:
WITHDRAWN
Last Update Posted:
2012-06-11
First Post:
2011-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'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'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003127', 'term': 'Colposcopy'}, {'id': 'D014626', 'term': 'Vaginal Smears'}, {'id': 'D057166', 'term': 'High-Throughput Screening Assays'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-08', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-03-09', 'lastUpdatePostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of anal dysplasia in women with cervical or vulvar dysplasia', 'timeFrame': 'Over 2 years'}, {'measure': 'HPV (Human Papillomavirus) status', 'timeFrame': 'Over 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervical Intraepithelial Neoplasia Grade 1', 'Cervical Intraepithelial Neoplasia Grade 2', 'Cervical Intraepithelial Neoplasia Grade 3', 'Recurrent Cervical Cancer', 'Recurrent Vaginal Cancer', 'Recurrent Vulvar Cancer', 'Stage 0 Cervical Cancer', 'Stage 0 Vaginal Cancer', 'Stage 0 Vulvar Cancer', 'Stage I Vaginal Cancer', 'Stage I Vulvar Cancer', 'Stage IA Cervical Cancer', 'Stage IB Cervical Cancer', 'Stage II Vaginal Cancer', 'Stage II Vulvar Cancer', 'Stage IIA Cervical Cancer', 'Stage IIB Cervical Cancer', 'Stage III Cervical Cancer', 'Stage III Vaginal Cancer', 'Stage III Vulvar Cancer', 'Stage IV Vulvar Cancer', 'Stage IVA Cervical Cancer', 'Stage IVA Vaginal Cancer', 'Stage IVB Cervical Cancer', 'Stage IVB Vaginal Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies colposcopy and high resolution anoscopy in screening for anal dysplasia in patients with cervical, vaginal, or vulvar dysplasia or cancer. Screening may help doctors find cancer cells early and plan better treatment for cancer', 'detailedDescription': 'OBJECTIVES:\n\nI. To evaluate the risk of anal dysplasia in women with cervical or vulvar dysplasia.\n\nOUTLINE:\n\nPatients undergo colposcopy and cervical Papanicolaou test with Human papillomavirus (HPV) test followed by anal Papanicolaou test and high resolution anoscopy. Patients with dysplastic anal lesions undergo repeat anoscopy at 3, 9, 15, and 24 months. Patients with normal anoscopy are followed up at 1 and 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmation of cervical, vaginal or vulvar intraepithelial neoplasia or cancer are included\n* Individuals treated with prior radiation therapy and/or chemotherapy are allowed\n* Women with high-grade dysplasia (carcinoma in situ) are eligible, regardless of their dysplasia free interval\n* HIV-positive (Human Immunodeficiency Virus) and HIV-negative women will be enrolled; HIV testing will not be performed as part of the study\n\nExclusion Criteria:\n\n* Women who are not able to consent are excluded'}, 'identificationModule': {'nctId': 'NCT01313104', 'briefTitle': 'Colposcopy and High Resolution Anoscopy in Screening For Anal Dysplasia in Patients With Cervical, Vaginal, or Vulvar Dysplasia or Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Pilot Project for Anal Dysplasia Screening in Women With Cervical or Vulvar Dysplasia', 'orgStudyIdInfo': {'id': 'NU 10G02'}, 'secondaryIdInfos': [{'id': 'NCI-2011-00112', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STU00039225', 'type': 'OTHER', 'domain': 'Northwestern University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening', 'description': 'See Detailed Description', 'interventionNames': ['Procedure: colposcopy', 'Other: cervical Papanicolaou test', 'Procedure: screening method']}], 'interventions': [{'name': 'colposcopy', 'type': 'PROCEDURE', 'description': 'Undergo colposcopy', 'armGroupLabels': ['Screening']}, {'name': 'cervical Papanicolaou test', 'type': 'OTHER', 'otherNames': ['cervical Pap test'], 'description': 'Undergo cervical Pap smear', 'armGroupLabels': ['Screening']}, {'name': 'screening method', 'type': 'PROCEDURE', 'description': 'Undergo anal Pap smear', 'armGroupLabels': ['Screening']}, {'name': 'screening method', 'type': 'PROCEDURE', 'description': 'Undergo high resolution anoscopy', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amy Halverson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}