Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-31 @ 12:39 AM
Study NCT ID:
NCT05934851
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2023-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014846', 'term': 'Vulvar 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'After randomization, the surgical assignment will be revealed to the attending surgeon. Subjects will remain blinded until the six-month post-operative study visit.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS', 'timeFrame': 'At the time of the resection', 'description': 'Comparison of rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS in subjects who undergo standard of care Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}], 'secondaryOutcomes': [{'measure': 'Recurrence rates at 6 months', 'timeFrame': '6 months post resection surgery', 'description': 'Comparison of recurrence rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Surgical time', 'timeFrame': 'At the time of the resection', 'description': 'Comparison of surgical time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Recovery room time', 'timeFrame': 'At the time of the resection and recovery', 'description': 'Comparison of recovery room time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Narcotic dose required (total during surgery and in recovery)', 'timeFrame': 'At the time of the resection and recovery', 'description': 'Comparison of narcotic dose required in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Blood loss', 'timeFrame': 'At the time of the resection', 'description': 'Comparison of blood loss in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Primary wound closure rates', 'timeFrame': '2-week post resection surgery', 'description': 'Comparison of primary wound closure rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Post-operative quality of life as determined by the SSQ-8', 'timeFrame': '2-weeks and 6 months after resection surgery', 'description': 'Comparison of post-operative quality of life as determined by the SSQ-8 in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Sexual function as determined by the FSFI', 'timeFrame': 'Screening and 6 months after resection surgery', 'description': 'Comparison of sexual function as determined by the FSFI in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}, {'measure': 'Wound bed size after surgery', 'timeFrame': 'End of resection surgery', 'description': 'Comparison of wound bed size after surgery in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulvar Neoplasm', 'Dysplasia Vulvar']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.', 'detailedDescription': 'This is a randomized, single-blinded study. The target population is adults ≥ 18 years of age with histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures. One group of subjects will be assigned to the Frozen-Section Directed Excision surgery arm and will undergo this procedure. The other group of subjects will be assigned to the Wide Local Excision (standard of care) arm and will undergo this procedure. The randomization will be 1:1, meaning for every subject who gets assigned to the Frozen-Section Directed Excision surgery arm, one will also be assigned to the Wide Local Excision arm. There is a 50% chance of getting randomized to either the Frozen-Section Directed Excision procedure or Wide Local Excision. Information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. The study team will also look at recurrence rates (return of the cancer) in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Age ≥ 18 years at the time of consent\n3. Histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures\n4. Surgery is expected to occur within 90 days from randomization\n5. Ability to read and understand the English and/or Spanish language\n6. As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study\n7. No known pregnancy\n\nExclusion Criteria:\n\n1. Excision is not possible due to anatomy (proximity to urethra/clitoris)\n2. Known immunodeficiency syndrome\n3. Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/immunosuppressant)\n4. History of pelvic region radiation therapy\n5. Active anticancer treatment'}, 'identificationModule': {'nctId': 'NCT05934851', 'briefTitle': 'A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia', 'orgStudyIdInfo': {'id': 'IRB00094930'}, 'secondaryIdInfos': [{'id': 'LCI-GYN-VUL-FSDE-001', 'type': 'OTHER', 'domain': 'Atrium Health'}, {'id': 'NCI-2024-03779', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Frozen-Section Directed Excision Vulvectomy', 'description': 'The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.', 'interventionNames': ['Procedure: Frozen-Section Directed Excision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wide Local Excision Vulvectomy', 'description': 'The surgeon(s) will visually identify the abnormal lesion. A Wide Local Excision with 5 mm margins will be made through the dermis per standard of care.', 'interventionNames': ['Procedure: Wide Local Excision']}], 'interventions': [{'name': 'Frozen-Section Directed Excision', 'type': 'PROCEDURE', 'otherNames': ['FSDE'], 'description': 'Frozen-Section Directed Excision (FSDE) is a surgical technique with evaluation of margin status during the surgical procedure, similar to the established Mohs Surgical Technique. The use of FSDE may ensure negative margins, decrease unnecessary excision of healthy tissue and has the potential to greatly reduce positive margins.', 'armGroupLabels': ['Frozen-Section Directed Excision Vulvectomy']}, {'name': 'Wide Local Excision', 'type': 'PROCEDURE', 'description': 'Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade Dysplasia NOS', 'armGroupLabels': ['Wide Local Excision Vulvectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maggie Dzhanumova', 'role': 'CONTACT', 'email': 'margarita.dzhanumova@advocatehealth.org', 'phone': '704-754-3768'}, {'name': 'Robert W Naumann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'centralContacts': [{'name': 'Maggie Dzhanumova', 'role': 'CONTACT', 'email': 'margarita.dzhanumova@advocatehealth.org', 'phone': '704-754-3768'}], 'overallOfficials': [{'name': 'Robert W Naumann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atrium Health Levine Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}