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Trial Title:
Genital Lichen Sclerosus - Epidemiology, Comorbidities and the Role of Vulvar and Penile Microbiome
NCT ID:
NCT05671263
Condition:
Lichen Sclerosus
Conditions: Official terms:
Lichen Sclerosus et Atrophicus
Conditions: Keywords:
lichen sclerosus
penis cancer
vulva cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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. 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. PART B: Swedish nationwide register-based cohort study to analyse incidence,
prevalence and comorbidities of genital LSc
Detailed description:
PART A: Microbiome study The participants will be included continuously at the
Dermatology clinic in connection with the regular doctor's visit. All cases included will
be asked to complete Dermatology Life Quality Index (DLQI) questionnaires. A first cotton
swab sample will be taken from a penile affected skin (including glans penis and coronal
sulcus) in men with genital LSc before treatment and from vulvar affected skin (including
mons pubis, labia minora and labia majora) in women with genital LSc before treatment. A
second cotton swab sample will be taken from the same sites at week 12 after the
treatment including both topical therapies and circumcision. The topical treatment will
be discontinued a week prior to visit. Allowed treatment options include topical and
systemic corticosteroids and topical calcineurin inhibitors (tacrolimus, pimecrolimus)
for both sexes and circumcision for men. In extreme resistant cases of genital LSc in
women even methotrexate, hydroxychloroquine will be recommended as systemic treatment.
The samples will be analyzed using 16S ribosomal RNA metagenomic sequencing to identify
the microbiome. Microbio analysis at Laboratory Medicine, Ryhov is today an established
method based on "next generation sequencing" (NGS) for analysis of 16S rDNA, which has
previously been used for analysis of skin and throat samples in psoriasis projects as
well as intestinal biopsies and faecal samples from patients with inflammatory bowel
disease. The microbial skin flora is sampled using a microbial swab (eNAT, Copan).
Taxonomic classification and a determination of numbers per sample of each taxonomic unit
is made on the basis of a reference database (Silva; https://www.arb-silva.de/) and
suitable bioinformatics analysis tools such as QIIME2 (https://qiime2.org/) and mothur
(https://mothur.org/). Group differences are examined with generalized linear models
adapted for number data (eg DESeq2 and glue; https://bioconductor.org/) in the
statistical programming environment R (https://cran.r-project.org/), and the analyzes are
corrected based on gender and age. The biochemical properties of the microbiome are
predicted using reference genomes based on the 16S composition of the samples using
PICRUSt2 (https://github.com/picrust/picrust2/wiki), and examined for group differences.
PART B:
- 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.
- Comorbidity will be determined.
Criteria for eligibility:
Study pop:
Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc
(controls). Adults only.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age over 18
- Genital LSc diagnosed by a dermatologist (cases) and individuals without genital LSc
(controls)
Exclusion Criteria:
- 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)
- Male patients already underwent circumcision as LSc treatment before inclusion into
the study
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Dermatology Ryhov County Hospital (Hudkliniken Länssjukhus Ryhov)
Address:
City:
Jönköping
Zip:
55439
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Sandra Jerkovic Gulin, MD, PhD, MSc
Phone:
010242 25106
Email:
sandra.jerkovicgulin@rjl.se
Investigator:
Last name:
Oliver Seifert, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Annika Bergman, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jan Söderman, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Linda Berglind
Email:
Sub-Investigator
Investigator:
Last name:
Charlotta Enerbäck, PhD Prof
Email:
Sub-Investigator
Investigator:
Last name:
Sandra Jerkovic Gulin, PhD
Email:
Principal Investigator
Start date:
January 14, 2022
Completion date:
January 30, 2024
Lead sponsor:
Agency:
Region Jönköping County
Agency class:
Other
Collaborator:
Agency:
FORSS, Forskningsrådet i Sydöstra Sverige
Agency class:
Other
Collaborator:
Agency:
Futurum - Academy for health and care
Agency class:
Other
Source:
Region Jönköping County
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671263
