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Trial Title:
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
NCT ID:
NCT05934851
Condition:
Vulvar Neoplasm
Dysplasia Vulvar
Conditions: Official terms:
Vulvar Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
After randomization, the surgical assignment will be revealed to the attending surgeon.
Subjects will remain blinded until the six-month post-operative study visit.
Intervention:
Intervention type:
Procedure
Intervention name:
Frozen-Section Directed Excision
Description:
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.
Arm group label:
Frozen-Section Directed Excision Vulvectomy
Other name:
FSDE
Intervention type:
Procedure
Intervention name:
Wide Local Excision
Description:
Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade
Dysplasia NOS
Arm group label:
Wide Local Excision Vulvectomy
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.
Detailed 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.
Criteria for eligibility:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alicia Patrick
Phone:
980-292-1746
Email:
alicia.patrick@atriumhealth.org
Investigator:
Last name:
Robert W Naumann, MD
Email:
Principal Investigator
Start date:
November 7, 2023
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
Atrium Health Levine Cancer Institute
Agency class:
Other
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934851
