A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
Running, not enrolling · Not applicable
Conditions studied: Vulvar Neoplasm, Dysplasia Vulvar
In brief
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.
Key facts
- Study ID
- NCT05934851
- Run by
- Wake Forest University Health Sciences
- People needed
- 112
- Starts
- 2023-11-07
- Expected to finish
- 2026-10-24
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Levine Cancer Institute — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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