Biomarkers of Lichen Sclerosus

NCT ID: NCT03561428

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2019-11-26

Brief Summary

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant lack of sexual pleasure or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The purpose of this study is to learn the gene expression file changes in skins affected by LS as compared to normal skins in order to discover the mechanism of the LS, and further to develop effective drugs to treat the condition.

Detailed Description

Lichen sclerosus (LS) is a chronic, lymphocyte mediated cutaneous disorder affecting approximately one in seventy women. Presenting symptoms may include intense pruritis, pain, burning, and dyspareunia. This disorder may affect any area of the skin, but has a notable predilection for the female genital region, in particular, the vulva, per anal area and the groin. Affected females outnumber affected males by 13:1. Typically, the patient is a menopausal woman, but prepubertal girls and women of all ages may be affected. The typical lesions of lichen sclerosus are white plaques and papules, often with areas of ecchymosis, excoriation, and ulceration. Often, there is destruction of the vulvar architecture with scarring of the clitoral prepuce, resorption of the labia minora, and narrowing of the introitus. Vulvar lichen sclerosus has a 4%-6% transformation malignant rate and women with the disease are at a 250-fold increased risk for developing vulvar carcinoma than women without lichen sclerosus. While the exact etiology of LS is as yet unknown, there is at least a suggested genetic component as evidenced by case reports of familial LS, findings of associations with HLA antigens, and high rates of concordance with other autoimmune disorder.

The purpose of this study is to determine the differences in the genomic/proteomic profiles between LS and normal skin biopsies for women with active vulvar lichen sclerosus in order to identify potential biomarkers that can be used for the prevention, early diagnosis and effective treatment for LS. The study will aim to identify genes/proteins/glycoproteins biomarkers that are associated with LS, select biomarkers associated with LS either individual candidate biomarker or as a panel, validate the identified candidate biomarkers for LS using targeted analysis of candidate biomarkers from independent LS specimen sets, develop assays to determine the clinical utilities of the identified biomarkers as minimum invasive tests for the early detection of LS and determine the clinical utility of biomarkers for biopsy-based tissue tests for LS diagnosis and treatment.

Conditions

Lichen Sclerosus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 18-75 of age
• Diagnosis of active, Histologically proven, vulvar lichen sclerosus

Exclusion Criteria

• Under the age of 18 or over the age of 75.
• Participants who are pregnant at the time of recruitment
• If, in the clinical opinion of Dr. Andrew Goldstein, she:

• does not have active LS
• has active infection
• has evidence of any other dermatologic disease of the vulva
• has evidence of neoplastic disease of the vulva
• If, in the opinion of Dr. Andrew Goldstein, they will be unable to keep the biopsy sites clean until they heal.
• If the biopsy specimen sent to dermatopathology is not confirmatory for active lichen sclerosus then the specimens obtained from that patient will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Cancer Research Foundation

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

Center for Vulvovaginal Disorders

OTHER

Sponsor Role: lead

Responsible Party

Andrew T. Goldstein, MD

Study Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Macri, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University School of Medicine and Health Sciences

Sidney Fu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University School of Medicine and Health Sciences

Andrew T Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Vulvovaginal Disorders

Locations

The Centers for Vulvovaginal Disorders

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrew T Goldstein, MD

Role: CONTACT

obstetrics@yahoo.com

4102790209

Charles Marci, MD

Role: CONTACT

202-741-2510

Facility Contacts

Andrew T Goldstein, MD

Role: primary

drg.cvvd@gmail.com

202-887-0568

Leia Mitchell, MD

Role: backup

drg.cvvd@gmail.com

(202)887-0568

Related Links

http://cvvd.org/research

Informed Consent

Other Identifiers

091739

Identifier Type: -

Identifier Source: org_study_id