Evaluating a new surgical method for vulvar dysplasia treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two surgical approaches for treating high-grade vulvar dysplasia: Frozen-Section Directed Excision and the standard Wide Local Excision. It is a randomized, single-blinded trial involving adults aged 18 and older with confirmed cases of vulvar neoplasia. Participants will be randomly assigned to one of the two surgical methods, and various outcomes such as surgery duration, pain medication usage, recurrence rates, and patient satisfaction will be assessed. The goal is to determine if the new method offers advantages over the standard approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Levine Cancer Institute
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Robert W Naumann, MD — Wake Forest University Health Sciences
• Study coordinator: Alicia Patrick
• Email: alicia.patrick@atriumhealth.org
• Phone: 980-292-1746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.