Biomarkers of Lichen Sclerosus
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|ClinicalTrials.gov Identifier: NCT03561428|
Recruitment Status : Unknown
Verified June 2018 by Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders.
Recruitment status was: Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||58 participants|
|Official Title:||Discovery and Validation of Biomarkers of Lichen Sclerosus|
|Actual Study Start Date :||November 27, 2017|
|Estimated Primary Completion Date :||November 26, 2019|
|Estimated Study Completion Date :||November 26, 2019|
- Differential gene expression between LS and normal vulvar skin tissue [ Time Frame: 1-2 year ]Gene expression obtained from biopsies via Next Generation Sequencing (RNASeq)
- Differential protein expression between LS and normal vulvar skin tissue [ Time Frame: 1-2 year ]Protein expression obtained from biopsies via Western blot
- Identification of tissue-derived glycoproteins in serum [ Time Frame: 1-2 years ]Glycoproteins identified via glycoproteomic technologies
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561428
|Contact: Andrew T Goldstein, MDemail@example.com|
|Contact: Charles Marci, MD||202-741-2510|
|United States, District of Columbia|
|The Centers for Vulvovaginal Disorders||Recruiting|
|Washington, District of Columbia, United States, 20037|
|Contact: Andrew T Goldstein, MD 202-887-0568 firstname.lastname@example.org|
|Contact: Leia Mitchell, MD (202)887-0568 email@example.com|
|Principal Investigator:||Charles Macri, MD||George Washington University School of Medicine and Health Sciences|
|Principal Investigator:||Sidney Fu, MD, PhD||George Washington University School of Medicine and Health Sciences|
|Principal Investigator:||Andrew T Goldstein, MD||The Center for Vulvovaginal Disorders|