Biomarkers of Lichen Sclerosus

Lichen Sclerosus Clinical Trial

Official title:

Discovery and Validation of Biomarkers of Lichen Sclerosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561428
• Other study ID #: 091739
• Status: Recruiting
• Start date: November 27, 2017
• Est. completion date: November 26, 2019

Study information

• Verified date: June 2018
• Source: Center for Vulvovaginal Disorders
• Contact: Andrew T Goldstein, MD
• Phone: 4102790209
• Email: obstetrics[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus

Locations

Country	Name	City	State
United States	The Centers for Vulvovaginal Disorders	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Center for Vulvovaginal Disorders	George Washington University, Gynecologic Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential gene expression between LS and normal vulvar skin tissue	Gene expression obtained from biopsies via Next Generation Sequencing (RNASeq)	1-2 year
Primary	Differential protein expression between LS and normal vulvar skin tissue	Protein expression obtained from biopsies via Western blot	1-2 year
Primary	Identification of tissue-derived glycoproteins in serum	Glycoproteins identified via glycoproteomic technologies	1-2 years

External Links

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