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New surgical technique aims to reduce cancer margins in vulvar dysplasia

NCT ID NCT05934851

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tests whether a surgery that uses frozen sections to guide removal (Frozen-Section Directed Excision) works better than the usual wide local excision for high-grade vulvar dysplasia. About 112 adults with confirmed high-grade dysplasia will be randomly assigned to one of the two surgeries. The main goal is to see which method leads to fewer positive margins (cancer cells left behind) and lower recurrence at 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

vulva cancer vulvar intraepithelial neoplasia vulvar neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysplasia vulvar Vulvar neoplasm

Contacts and locations

Locations

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.