Clinical trial · Interventional
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia
NCT05934851CI-TRIAL-00117652active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysplasia Vulvar | — | UNRESOLVED | — |
| Vulvar Neoplasm | Vulvar Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frozen-Section Directed Excision | Procedure | — | UNRESOLVED |
| Wide Local Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Frozen-Section Directed Excision Vulvectomy
- description
- The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.
- interventionNames
- Procedure: Frozen-Section Directed Excision
- type
- ACTIVE_COMPARATOR
- label
- Wide Local Excision Vulvectomy
- description
- 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.
- interventionNames
- Procedure: Wide Local Excision
Primary outcomes (1)
- measure
- Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.