Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03561428
Status:
UNKNOWN
Last Update Posted:
2018-06-19
First Post:
2018-01-02
Brief Title:
Biomarkers of Lichen Sclerosus
Sponsor:
Center for Vulvovaginal Disorders
Organization:
Center for Vulvovaginal Disorders
Study Overview
Official Title:
Discovery and Validation of Biomarkers of Lichen Sclerosus
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 131 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 genomicproteomic 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 genesproteinsglycoproteins 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
The purpose of this study is to determine the differences in the genomicproteomic 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 genesproteinsglycoproteins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None