Cellular and Molecular Biomarkers in Patients With Lichen Planus

Official title

Evaluation of the Clinical Specificity of Cellular and Molecular Biomarkers Identified in Patients With Lichen Planus

Overview

Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. In previous work, T cell antigen receptor (TCR) repertoire studies were performed. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.

Detailed description

Lichen planus (LP) is a chronic inflammatory disease of unknown aetiology, affecting the skin and mucous membranes, characterised by a CD8+ cytotoxic T-cell infiltrate, associated with epithelial cell death and disruption of the basement membrane zone. Several triggers have been proposed for LP, including viral antigens. In previous work, T cell antigen receptor (TCR) repertoire studies were performed, i.e. investigating the diversity of TCRs expressed on the surface of an individual's lymphocyte population. In all patients tested, whether with erosive or non-erosive LP, unique nucleotide sequences, called clonotypes, have been identified. They appear during the process of TCR gene rearrangement. These clonotypes are specific for human papillomavirus (HPV) in blood and lesions, suggesting antigenic stimulation of these clonotypes by a viral epitope of HPV, which crosses with an epitope on keratinocytes. The diagnosis of LP is made on the basis of clinical and histological criteria, but in some patients and in some anatomical locations, the diagnosis is difficult to make and LP may be confused with other skin conditions.

Interventions

• Other Blood samples collection
  50 mL blood sample
• Other Skin or mucous membrane brushing
  brushing on skin or mucous membrane lesions
• Other Skin or mucous membrane biopsy
  6 mm biopsy

Primary outcome measures

• Identification of TCR repertoire by flow cytometry [Time frame: 3 years]

Secondary outcome measures (2)

• Identification of characteristic biomarkers of lichen [Time frame: 3 years]
• Identification of T CD8 clonotypes [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• Subject coming at the time of diagnosis of the disease before any systemic treatment, or at the time of a progressive episode of the disease, without systemic treatment or after cessation of immunomodulatory or immunosuppressive treatment
• Ability to give their consent in writing
• Must understand spoken and written French
• Affiliated to the French social security or assimilated regimes

Exclusion criteria

• Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 6 centers

• CHU de Besançon — Besançon
• CHU Paris Seine-Saint-Denis- Hôpital Avicenne — Bobigny
• Centre Medical de l'Institut Pasteur — Paris
• Hôpital Saint-Louis — Paris
• Hôpital Robert Debré, CHU de Reims — Reims
• CHU de Rouen — Rouen

Identifiers

NCT: NCT06451744 · 2021-048

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗