Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06358469
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 249}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2031-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'HPV-I and HPV-A VSCC cohorts: Recurrence-free survival', 'timeFrame': '3 years'}, {'measure': 'HPV-I and HPV-A VSCC cohorts: Disease-specific survival', 'timeFrame': '3 years'}, {'measure': 'HPV-I and HPV-A VSCC cohorts: Overall-survival', 'timeFrame': '3 years'}, {'measure': 'HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L', 'timeFrame': '3 years'}, {'measure': 'HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30', 'timeFrame': '3 years'}, {'measure': 'HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34', 'timeFrame': '3 years'}, {'measure': 'HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale', 'timeFrame': '3 years'}, {'measure': 'HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulvar Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?', 'detailedDescription': 'This study is being done to find out if these approaches are better or worse than the usual approach for early-stage vulvar cancer. The usual approach is defined as care most people get for early-stage vulvar cancer.\n\nThe usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor in deciding whether additional surgery should be recommended.\n\nFor patients deciding to take part in this study, the treatment that will be recommended will be based on laboratory testing of the cancer. The laboratory assessments include a test to determine if the cancer is caused by the Human Papilloma Virus (HPV) or not caused by HPV. If the laboratory test results show the vulvar cancer is caused by HPV, the study doctor will recommend the patient participate in sub-study A. In sub-study A, the patient will receive no additional surgery (observation). If the laboratory test results show the vulvar cancer is not caused by HPV, the study doctor will recommend the patient participate in sub-study B. In sub-study B, patients will receive either a second surgery or no additional surgery (observation).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma (VSCC)\n* Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines\n* Vulvar resection according to standard of care guidelines\n* Post-operative margin assessment of tumour clearance, dVIN and p53 status.\n* Participants' age must be ≥ 18 years old\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French\n* Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements\n\nExclusion Criteria:\n\n* Recurrent vulvar squamous cell carcinoma\n* Non-squamous cell carcinoma histotypes\n* Participants referred for/receiving/or previously received adjuvant vulvar radiation or chemotherapy\n* Primary tumour HPV-I p53 wild-type VSCC\n* Surgical margins positive for invasive cancer.\n* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n* Lymph node positive VSCC"}, 'identificationModule': {'nctId': 'NCT06358469', 'acronym': 'STRIVE', 'briefTitle': 'STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision', 'orgStudyIdInfo': {'id': 'VU2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sub-Study A: Active Surveillance', 'description': 'If the laboratory test results show vulvar cancer is caused by HPV', 'interventionNames': ['Other: Active Surveillance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sub-Study B: Re-excision', 'description': 'If the laboratory test results show vulvar cancer is not caused by HPV', 'interventionNames': ['Procedure: Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sub-Study B: Active Surveillance', 'description': 'If the laboratory test results show vulvar cancer is not caused by HPV', 'interventionNames': ['Other: Active Surveillance']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Re-excision of vulvar cancer margin', 'armGroupLabels': ['Sub-Study B: Re-excision']}, {'name': 'Active Surveillance', 'type': 'OTHER', 'description': "The investigator will follow the patient to watch for side effects and keep track of patient's health", 'armGroupLabels': ['Sub-Study A: Active Surveillance', 'Sub-Study B: Active Surveillance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Amy Jamieson', 'role': 'CONTACT', 'phone': '604 729-1258'}], 'facility': 'BCCA - Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Julie My Van Nguyen', 'role': 'CONTACT', 'phone': '905 387-9495'}], 'facility': 'Juravinski Cancer Centre at Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lilian Gien', 'role': 'CONTACT', 'phone': '416 480-4329'}], 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Annick Pina', 'role': 'CONTACT', 'phone': '514 890-8444'}], 'facility': "CHUM-Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marie Plante', 'role': 'CONTACT', 'phone': '418 691-5392'}], 'facility': 'Hotel-Dieu de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Bessette', 'role': 'CONTACT', 'phone': '819 346-1110', 'phoneExt': '13120'}], 'facility': "CIUSSS de l'Estrie - Centre hospitalier", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Wendy Parulekar', 'role': 'CONTACT', 'email': 'wparulekar@ctg.queensu.ca', 'phone': '613-533-6430'}], 'overallOfficials': [{'name': 'Amy Jamieson', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia, Vancouver, BC, Canada'}, {'name': 'Jessica McAlpine', 'role': 'STUDY_CHAIR', 'affiliation': 'BCCA-Vancouver Cancer Centre, Vancouver, BC Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Cancer Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Australia New Zealand Gynaecological Oncology Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}