Active — Not RecruitingNot Applicable

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

United States112 participantsStarted 2023-11-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS

Timeframe: At the time of the resection

Trial details

NCT IDNCT05934851

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

View on ClinicalTrials.gov More Vulvar Neoplasm trials