Lichen SclerosusNCT03561428
Biomarkers of Lichen Sclerosus
An observational study of Lichen Sclerosus, run by Center for Vulvovaginal Disorders at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lichen Sclerosus
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 26 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Adult, Older adult
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
Who may be able to join
- 18-75 of age
- Diagnosis of active, Histologically proven, vulvar lichen sclerosus
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Charles Marci, MD contact
United States1 site, 1 recruiting
- Recruiting
The Centers for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
Andrew T Goldstein, MD, 202-887-0568, drg.cvvd@gmail.com
Leia Mitchell, MD, (202)887-0568, drg.cvvd@gmail.com
About this study
Official title: Discovery and Validation of Biomarkers of Lichen Sclerosus
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.
Read the 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
- Keywords
- lichen sclerosus
- Medical subject headings
- Lichen Sclerosus et Atrophicus
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential gene expression between LS and normal vulvar skin tissue
Gene expression obtained from biopsies via Next Generation Sequencing (RNASeq)
Measured: 1-2 year
Differential protein expression between LS and normal vulvar skin tissue
Protein expression obtained from biopsies via Western blot
Measured: 1-2 year
Identification of tissue-derived glycoproteins in serum
Glycoproteins identified via glycoproteomic technologies
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start27 Nov 2017
- Primary completion26 Nov 2019 (estimated)
- Study completion26 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vulvovaginal Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Gynecologic Cancer Research Foundation, George Washington University
- Responsible party
- Principal investigator, Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders
- Investigators
- Charles Macri, MD, Principal investigator, George Washington University School of Medicine and Health SciencesSidney Fu, MD, PhD, Principal investigator, George Washington University School of Medicine and Health SciencesAndrew T Goldstein, MD, Principal investigator, The Center for Vulvovaginal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561428
- Sponsor's protocol ID
- 091739
- Status last verified
- Jun 2018
- First submitted
- 2 Jan 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery and Validation of Biomarkers of Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT03561428
- Acronym / sponsor ID
- 091739
- Conditions
- Lichen Sclerosus
- Keywords
- lichen sclerosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Center for Vulvovaginal DisordersUniversity, hospital or other
- Collaborators
- Gynecologic Cancer Research Foundation, George Washington University
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 26 Nov 2019 (estimated)
- Study completion
- 26 Nov 2019 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 18-75 of age
- Diagnosis of active, Histologically proven, vulvar lichen sclerosus
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Informed ConsentLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Marci, MD contact
Charles Macri, MD principal investigator
George Washington University School of Medicine and Health Sciences
Sidney Fu, MD, PhD principal investigator
George Washington University School of Medicine and Health Sciences
Andrew T Goldstein, MD principal investigator
The Center for Vulvovaginal Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Sclerosus, run by Center for Vulvovaginal Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew T Goldstein, MD (4102790209, obstetrics@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential gene expression between LS and normal vulvar skin tissue (time frame: 1-2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.