NCT05934851

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Nov 2023Mar 2027

First Submitted

Initial submission to the registry

June 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 7, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

June 28, 2023

Last Update Submit

April 29, 2026

Conditions

Vulvar NeoplasmDysplasia Vulvar

Outcome Measures

Primary Outcomes (1)

  • Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS

    Comparison of rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS in subjects who undergo standard of care Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision

    At the time of the resection

Secondary Outcomes (9)

  • Recurrence rates at 6 months

    6 months post resection surgery

  • Surgical time

    At the time of the resection

  • Recovery room time

    At the time of the resection and recovery

  • Narcotic dose required (total during surgery and in recovery)

    At the time of the resection and recovery

  • Blood loss

    At the time of the resection

  • +4 more secondary outcomes

Study Arms (2)

Frozen-Section Directed Excision Vulvectomy

EXPERIMENTAL

The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.

Procedure: Frozen-Section Directed Excision

Wide Local Excision Vulvectomy

ACTIVE COMPARATOR

The surgeon(s) will visually identify the abnormal lesion. A Wide Local Excision with 5 mm margins will be made through the dermis per standard of care.

Procedure: Wide Local Excision

Interventions

Frozen-Section Directed ExcisionPROCEDURE

Frozen-Section Directed Excision (FSDE) is a surgical technique with evaluation of margin status during the surgical procedure, similar to the established Mohs Surgical Technique. The use of FSDE may ensure negative margins, decrease unnecessary excision of healthy tissue and has the potential to greatly reduce positive margins.

Also known as: FSDE
Frozen-Section Directed Excision Vulvectomy
Wide Local ExcisionPROCEDURE

Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade Dysplasia NOS

Wide Local Excision Vulvectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Robert W Naumann, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
After randomization, the surgical assignment will be revealed to the attending surgeon. Subjects will remain blinded until the six-month post-operative study visit.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

November 7, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)