A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia

Conditions
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Vulvar Neoplasm, Dysplasia Vulvar

Intervention / Treatment
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* Procedure: Frozen-Section Directed Excision
* Procedure: Wide Local Excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information. Age ≥ 18 years at the time of consent 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 Surgery is expected to occur within 90 days from randomization Ability to read and understand the English and/or Spanish language As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study No known pregnancy Exclusion Criteria: Excision is not possible due to anatomy (proximity to urethra/clitoris) Known immunodeficiency syndrome Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/immunosuppressant) History of pelvic region radiation therapy Active anticancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frozen-Section Directed Excision Vulvectomy<br>The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site. | Procedure: Frozen-Section Directed Excision<br>* 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.<br>* Other names: FSDE;|
| Active Comparator: Wide Local Excision Vulvectomy<br>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. | Procedure: Wide Local Excision<br>* Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade Dysplasia NOS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS | 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 | At the time of the resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rates at 6 months | Comparison of recurrence rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | 6 months post resection surgery | 
| Surgical time | Comparison of surgical time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | At the time of the resection | 
| Recovery room time | Comparison of recovery room time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | At the time of the resection and recovery | 
| Narcotic dose required (total during surgery and in recovery) | Comparison of narcotic dose required in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | At the time of the resection and recovery | 
| Blood loss | Comparison of blood loss in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | At the time of the resection | 
| Primary wound closure rates | Comparison of primary wound closure rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | 2-week post resection surgery | 
| Post-operative quality of life as determined by the SSQ-8 | 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 | 2-weeks and 6 months after resection surgery | 
| Sexual function as determined by the FSFI | 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 | Screening and 6 months after resection surgery | 
| Wound bed size after surgery | Comparison of wound bed size after surgery in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision | End of resection surgery |