Evaluating a new surgical method for vulvar dysplasia treatment
A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia
This study is testing a new surgical method for treating vulvar dysplasia to see if it works better than the standard surgery for adults with this condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT05934851 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed high-grade vulvar dysplasia who can undergo excisional surgery.
Not a fit: Patients with anatomical issues preventing excision or those with known immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction for those with vulvar dysplasia.
How similar studies have performed: Previous studies have shown promise with similar surgical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlotte, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.