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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
Sponsor:
Collaborators:
Gynecologic Cancer Research Foundation
George Washington University
Information provided by (Responsible Party):
Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders

Study Description
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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.

Condition or disease
Lichen Sclerosus

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. Differential protein expression between LS and normal vulvar skin tissue [ Time Frame: 1-2 year ]
    Protein expression obtained from biopsies via Western blot

  3. Identification of tissue-derived glycoproteins in serum [ Time Frame: 1-2 years ]
    Glycoproteins identified via glycoproteomic technologies


Biospecimen Retention:   Samples With DNA
All samples obtained in this study will be processed for RNA, protein and DNA extraction, which will be used for gene expression analysis. The samples collected will be snap-frozen in liquid nitrogen before transporting, and store in a -80C degree freezer in the Department of Medicine at the George Washington University School of Medicine in Ross Hall for a period of 5 years for further verification studies if needed, and then they will be destroyed unless the patient has consented to future research on their samples. The patient's name will not be on these specimens, but will instead be given a study number.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The total number of subjects to expected to be recruited are 58 total.

  • six families with 2-3 family members affected in each family with LS
  • 40 patients (sporadic) with active lichen sclerosus
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Andrew T Goldstein, MD 4102790209 obstetrics@yahoo.com
Contact: Charles Marci, MD 202-741-2510

Locations
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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    drg.cvvd@gmail.com   
Contact: Leia Mitchell, MD    (202)887-0568    drg.cvvd@gmail.com   
Sponsors and Collaborators
Center for Vulvovaginal Disorders
Gynecologic Cancer Research Foundation
George Washington University
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Andrew T. Goldstein, MD, Study Investigator, Center for Vulvovaginal Disorders
ClinicalTrials.gov Identifier: NCT03561428    
Other Study ID Numbers: 091739
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be summarized in publication and presentation. Individual results will not be communicated, and nor the study participants will be contacted about their results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders:
lichen sclerosus
Additional relevant MeSH terms:
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Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases