A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia

Vulvar Neoplasm Clinical Trial

Official title:

A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934851
• Other study ID #: IRB00094930
• Secondary ID: LCI-GYN-VUL-FSDE
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Alicia Patrick
• Phone: 980-292-1746
• Email: alicia.patrick[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, single-blinded study. The target population is adults ≥ 18 years of age with 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. One group of subjects will be assigned to the Frozen-Section Directed Excision surgery arm and will undergo this procedure. The other group of subjects will be assigned to the Wide Local Excision (standard of care) arm and will undergo this procedure. The randomization will be 1:1, meaning for every subject who gets assigned to the Frozen-Section Directed Excision surgery arm, one will also be assigned to the Wide Local Excision arm. There is a 50% chance of getting randomized to either the Frozen-Section Directed Excision procedure or Wide Local Excision. Information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. The study team will also look at recurrence rates (return of the cancer) in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 1, 2027
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Neoplasm
• Vulvar Neoplasms

Intervention

Procedure:
• Frozen-Section Directed Excision
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.
• Wide Local Excision
Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade Dysplasia NOS

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence rates at 6 months	Comparison of recurrence rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	6 months post resection surgery
Secondary	Surgical time	Comparison of surgical time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	At the time of the resection
Secondary	Recovery room time	Comparison of recovery room time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	At the time of the resection and recovery
Secondary	Narcotic dose required (total during surgery and in recovery)	Comparison of narcotic dose required in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	At the time of the resection and recovery
Secondary	Blood loss	Comparison of blood loss in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	At the time of the resection
Secondary	Primary wound closure rates	Comparison of primary wound closure rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	2-week post resection surgery
Secondary	Post-operative quality of life as determined by the SSQ-8	Comparison of post-operative quality of life as determined by the SSQ-8 in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	2-weeks and 6 months after resection surgery
Secondary	Sexual function as determined by the FSFI	Comparison of sexual function as determined by the FSFI in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	Screening and 6 months after resection surgery
Secondary	Wound bed size after surgery	Comparison of wound bed size after surgery in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision	End of resection surgery