Clinical trial NCT05934851: A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
Official title: A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvar Neoplasm
Dysplasia Vulvar
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2023-07-07
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.
2. Age ≥ 18 years at the time of consent
3. 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
4. Surgery is expected to occur within 90 days from randomization
5. Ability to read and understand the English and/or Spanish language
6. As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study
7. No known pregnancy

Exclusion Criteria:

1. Excision is not possible due to anatomy (proximity to urethra/clitoris)
2. Known immunodeficiency syndrome
3. Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/immunosuppressant)
4. History of pelvic region radiation therapy
5. Active anticancer treatment

Primary outcomes:
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
Secondary outcomes:
measure: Recurrence rates at 6 months
timeFrame: 6 months post resection surgery
measure: Surgical time
timeFrame: At the time of the resection
measure: Recovery room time
timeFrame: At the time of the resection and recovery
measure: Narcotic dose required (total during surgery and in recovery)
timeFrame: At the time of the resection and recovery
measure: Blood loss
timeFrame: At the time of the resection
measure: Primary wound closure rates
timeFrame: 2-week post resection surgery
measure: Post-operative quality of life as determined by the SSQ-8
timeFrame: 2-weeks and 6 months after resection surgery
measure: Sexual function as determined by the FSFI
timeFrame: Screening and 6 months after resection surgery
measure: Wound bed size after surgery
timeFrame: End of resection surgery
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Robert W Naumann, MD
role: PRINCIPAL_INVESTIGATOR
References: