Cellular and Molecular Biomarkers in Patients With Lichen Planus
- Conditions
- Lichen Planus
- Interventions
- Other: Blood samples collectionOther: Skin or mucous membrane brushingOther: Skin or mucous membrane biopsy
- Registration Number
- NCT06451744
- Lead Sponsor
- Institut Pasteur
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- Dermatosis exclusively localised in the skin folds or on the face (risk of scarring from biopsies)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pseudopelade of Brocq Blood samples collection Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 lichen planus with scalp involvement Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 Pseudopelade of Brocq Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 lichen planus with nail involvement Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 Oral lichen planus erosive Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 and 2 (6 month after first visit) * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 and 2 mucosal pemphigoid with oral lesions Blood samples collection Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 Oral lichen planus erosive Blood samples collection Human biological samples : * blood samples collection at visit 1 and 2 (6 month after first visit) * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 and 2 Oral lichen planus erosive Skin or mucous membrane biopsy Human biological samples : * blood samples collection at visit 1 and 2 (6 month after first visit) * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 and 2 mucosal pemphigoid with oral lesions Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 lichen planus with scalp involvement Blood samples collection Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 Pseudopelade of Brocq Skin or mucous membrane biopsy Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 * skin or mucous membrane biopsy at visit 1 lichen planus with nail involvement Blood samples collection Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 psoriasis and specific nail involvement Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 psoriasis and specific nail involvement Blood samples collection Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 Lichenoid graft-versus-host disease Blood samples collection Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1 Lichenoid graft-versus-host disease Skin or mucous membrane brushing Human biological samples : * blood samples collection at visit 1 * brushing on skin or mucous membrane lesions at visit 1
- Primary Outcome Measures
Name Time Method Identification of TCR repertoire by flow cytometry 3 years Determination by flow cytometry and PCR testing for TCR repertoire bias
- Secondary Outcome Measures
Name Time Method Identification of characteristic biomarkers of lichen 3 years Identify complementary biomarkers characterising lichen by quantitative PCR
Identification of T CD8 clonotypes 3 years Measurement of the antigenic specificity of identified T CD8 clonotypes by flow cytometry
Trial Locations
- Locations (5)
CHU de Besançon
🇫🇷Besançon, France
CHU Paris Seine-Saint-Denis- Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital Saint-Louis
🇫🇷Paris, France
Hôpital Robert Debré, CHU de Reims
🇫🇷Reims, France
CHU de Rouen
🇫🇷Rouen, France