Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome

NCT05671263 | Unknown

• 1 other identifier: EPM 2020-xxxxx
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In genital LSc, three pathological processes are implicated in disease development: inflammation, sclerosis/fibrosis and neoplasia. The role of genital microbiome is still to be investigated and explained. Genital LSc microbiome studies are missing. The ecological community of microorganisms that are present on our body and of the body itself defines the human skin microbiome. Revealing the genital microbiome may potentially lead to new therapies of genital LSc. The primary aim is to analyze genital microbiome before and after the treatment (topical corticosteroids or topical calcineurin inhibitors or circumcision) in both male and female patients diagnosed with genital LSc as well as to analyze genital microbiome in healthy (non-genital LSc) controls. 2) The secondary aim is to determine incidence and prevalence of male and female genital LSc in Sweden and its association with other diseases. The Study will be divided in two parts

1. 1.PART A: Prospective case control study on the effect of treatment on the genital skin microbiome of patients with genital LSc and on the role of genital microbiome in treatment resistance of genital LSc
2. 2.PART B: Swedish nationwide register-based cohort study to analyse incidence, prevalence and comorbidities of genital LSc

Conditions

Lichen Sclerosus

Keywords

lichen sclerosus; penis cancer; vulva cancer

Outcome Measures

Primary Outcomes (3)

• Quality of life in patients with genital lichen sclerosus (The Dermatology Life Quality Index -DLQI)

  DLQI questionnaire data will be analysed, the DLQI score will be calculated 0-30 (higher the score, more effect on patient´s quality of life)

  24 months

• The role of genital microbiome in the treatment resistance of genital LSc

  analysis of genital microbiome will be performed, 16S ribosomal RNA metagenomic sequencing will be conducted on samples.

  24 months

• Lichen slerosus comorbidity will be determined in a register study

  A retrospective nationwide cohort study will be conducted using national Swedish registers (National Patient Register, Swedish Cancer Register) and LISA database (Longitudinal integration database for health insurance and labor market studies). The patients diagnosed with LSc (ICD-10 diagnosis code - L90) during 20-years period between January 1, 2001 and January 1, 2021 will be selected

  24 months

Study Arms (4)

cases women LSc

women with LSc- vulvar lesional skin (including mons pubis, labia minora and labia majora) in women with genital LSc

cases men LSc

men with LSc -penile lesional skin (including glans penis and coronal sulcus) in men with genital LSc

control women

women without genital disease

control men

men without genital disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls). Adults only.

You may qualify if:

• Age over 18
• Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc (controls)

You may not qualify if:

• Age under 18
• Pregnancy
• Current diagnosis of cancer or ongoing treatment for cancer (not applicable for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of extra-genital localization)
• Ongoing systemic anti-inflammatory and/or immunomodulating treatment or having discontinued such treatment within the last week
• Ongoing treatment with systemic antibiotics or having discontinued such treatment within the last week
• Treatment with topical antibiotics, topical corticosteroids and/or topical calcineurin inhibitors (tacrolimus, pimecrolimus) on the sampling area within the last week
• Having used antiseptics and disinfectants on the sampling area 24 hours prior to the samples being taken
• Persons not understanding Swedish or not being able to leave consent to participate

Sponsors & Collaborators

• Region Jönköping County: lead
• FORSS, Forskningsrådet i Sydöstra Sverige: collaborator
• Futurum - Academy for health and care: collaborator

Study Sites (1)

Department of Dermatology Ryhov County Hospital (Hudkliniken Länssjukhus Ryhov)

Jönköping, 55439, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cotton swab sample will be taken from a penile lesional skin in men with genital LSc before treatment and from vulvar lesional skin in women with genital LSc before treatment and after the treatment. The same procedure with healthy controls.

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus; Penile Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Genital Neoplasms, Female; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Oliver Seifert, PhD AssProf

  Länssjukhuset Ryhov, Hudkliniken

  STUDY CHAIR

• Jan Söderman, PhD AssProf

  Länssjukhuset Ryhov, Division of Microbiology

  STUDY CHAIR

• sandra j gulin, PhD

  Länssjukhuset Ryhov, Hudkliniken

  PRINCIPAL INVESTIGATOR

• Annika Bergman, PhD

  Länssjukhuset Ryhov, Division of Microbiology

  STUDY CHAIR

• Linda Berglind

  Länssjukhuset Ryhov, Division of Microbiology

  STUDY CHAIR

• Charlotta Enerbäck, PhD Prof

  Department of Biomedical and Clinical Sciences, Faculty of Health Sciences, Linköping University

  STUDY CHAIR

Central Study Contacts

Sandra Jerkovic Gulin, PhD,MSc

CONTACT

010 242 25106; sandra.jerkovicgulin@rjl.se

Oliver Seifert, PhD AssProf

CONTACT

oliver.seifert@rjl.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 4, 2023
• Study Start: January 14, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)