Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03061435
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar 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': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer', 'timeFrame': '6 months to 1 year'}], 'secondaryOutcomes': [{'measure': 'Prevalence of AIN in women with VIN 2/3 or vulvar cancer', 'timeFrame': '6 months to 1 year'}, {'measure': 'Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN', 'timeFrame': '6 months to 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vulvar Cancer', 'Cervical Cancer', 'Vulvar Dysplasia', 'Cervical Dysplasia', 'Anal Cancer', 'Anal Dysplasia', 'HPV'], 'conditions': ['Vulvar Cancer', 'Cervical Cancer', 'Vulvar Dysplasia', 'Cervical Dysplasia', 'Anal Cancer', 'Anal Dysplasia', 'HPV-Related Anal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.\n\nHypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age ≥ 40\n* Previous diagnosis of VIN 2/3 or vulvar\n\nExclusion Criteria:\n\n* Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer\n* Women who are HIV positive\n* Women currently taking immunosuppressant medication\n* Women who have had a previous hysterectomy'}, 'identificationModule': {'nctId': 'NCT03061435', 'acronym': 'Vulvar-AIN', 'briefTitle': 'Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.', 'orgStudyIdInfo': {'id': 'GYNEOCC 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Screening anal Pap Smear - Negative (75%)', 'description': 'All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.', 'interventionNames': ['Procedure: Screening anal Pap smear - No high-resolution anoscopy']}, {'type': 'OTHER', 'label': 'Screening anal Pap Smear - Negative (25%)', 'description': 'All patients will receive an anal Pap test. Remaining 25% of patients will proceed to high-resolution anoscopy (HRA) clinic to assess the negative predictive rate of HRA.', 'interventionNames': ['Procedure: Screening anal Pap smear - High-resolution anoscopy']}, {'type': 'OTHER', 'label': 'Screening anal Pap Smear - Positive', 'description': 'All patients will receive an anal Pap test. Any patient with abnormal cytology on their Pap test will be referred to HRA clinic for management. This includes potential biopsy and treatment.', 'interventionNames': ['Procedure: Screening anal Pap smear - High-resolution anoscopy']}], 'interventions': [{'name': 'Screening anal Pap smear - No high-resolution anoscopy', 'type': 'PROCEDURE', 'description': '75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy', 'armGroupLabels': ['Screening anal Pap Smear - Negative (75%)']}, {'name': 'Screening anal Pap smear - High-resolution anoscopy', 'type': 'PROCEDURE', 'description': '25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.', 'armGroupLabels': ['Screening anal Pap Smear - Negative (25%)', 'Screening anal Pap Smear - Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dr. Danielle Vicus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Nithla Mohanathas, BSc', 'role': 'CONTACT', 'email': 'nithla.mohanathas@sunnybrook.ca', 'phone': '4164805000', 'phoneExt': '85838'}, {'name': 'Anika Mohan, BSc', 'role': 'CONTACT', 'email': 'anika.mohan@sunnybrook.ca', 'phone': '4164805000', 'phoneExt': '89828'}], 'overallOfficials': [{'name': 'Danielle Vicus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odette Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Danielle Vicus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Danielle Vicus, MD, MSc, FRCSC', 'investigatorFullName': 'Dr. Danielle Vicus', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}