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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a surgical technique called "Frozen-Section Directed Excision" to treat a condition known as high-grade vulvar dysplasia, which is a precancerous change in the skin of the vulva. This method is being compared to the standard surgery known as "Wide Local Excision" to see if it is more effective. The trial is currently looking for women aged 18 and older who have been diagnosed with specific types of vulvar dysplasia and who can consent to participate in the study.

Eligible participants will need to provide consent and may expect to undergo surgery within 90 days of joining the trial. They should be able to understand English or Spanish and are not currently pregnant. However, there are some exclusions, such as if the surgery is too complicated due to the location, or if there are certain health conditions like active cancer treatment or a weakened immune system. By participating, women may help researchers learn more about the best ways to treat this condition, potentially improving outcomes for future patients.

Gender

FEMALE

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