RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-07

Study Completion:2027-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05934851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Alicia Patrick

CONTACT

980-292-1746

alicia.patrick@atriumhealth.org

Principal Investigator

Robert W Naumann, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Robert W Naumann, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07

Study Completion Date2027-03-01

Study Record Updates

Study Start Date2023-11-07

Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

Vulvar Neoplasm
Dysplasia Vulvar