Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen) (HPVLichen)
Primary Purpose
Lichen Planus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Human biological samples
Sponsored by
About this trial
This is an interventional basic science trial for Lichen Planus
Eligibility Criteria
Inclusion Criteria:
- At least 18 year-old
- Clinically or histologically confirmed lichen : Non-erosive lichen planus, Erosive lichen planus, or Sclerosus lichen
- At diagnosis of desease before treatment, or during flares of the disease, with or without intake or topical application of immunosuppressants
- Affiliated or beneficiary of a social security system
- Informed and written consent
Exclusion Criteria:
- Under 18 year-old,
- Legal protection measures,
- Inability to consent
- Pregnant or breastfeeding women.
Sites / Locations
- Service de Dermatologie du CHU de Besançon
- Service de Dermatologie de l'hôpital Saint Louis
- Service de Dermatologie du CHU de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with lichen
Arm Description
Patients with non-erosive lichen planus, erosive lichen planus or lichen sclerosus. Human biological samples : Blood sample Skin or mucosal brushing Skin or mucosal biopsy
Outcomes
Primary Outcome Measures
The use of the different segments of the Vbeta gene assessed by quantitative PCR, and the distribution of the different sizes of the complementarity determining regions (CDR) CDR3 by immunoscope.
In patients with a non-erosive type of lichen and with a lichen sclerosus et atrophicus, the hypothesis for oligoclonal bias in the T-cell receptor repertoire on peripheral and in situ CD4 and CD8 T lymphocytes will be tested realizing, on the 2 sorted subpopulations, a study of the use of the different segments of the Vbeta gene using quantitative Polymerase Chain Reaction (PCR) and a study of the distribution study of the different sizes of the CDR3 using immunoscope method.
Depending on whether or not bias in the T-cell receptor repertoire exists, the study will be continued by looking for the same repertoire bias in situ, on injury site (skin or mucous, depending on the clinical type of lichen), and the research of clonal sequences (or clonotypes) from RNA of patients after cloning and complete sequencing. If clonotype T CD8 Vbeta3 are identified in these types of lichen, their specificity to HPV16 E711-20 wil be assessed by flow cytometry.
Secondary Outcome Measures
The functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes assessed by flow cytometry.
In patients with erosive lichen planus, the functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes will be assessed showing their ability to recognize and destroy a target carrier of HPV16 E711-20 peptide by flow cytometry.
Full Information
NCT ID
NCT02761122
First Posted
April 22, 2016
Last Updated
February 14, 2022
Sponsor
Institut Pasteur
Collaborators
Société de Dermatologie Française
1. Study Identification
Unique Protocol Identification Number
NCT02761122
Brief Title
Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen)
Acronym
HPVLichen
Official Title
Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2016 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
April 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Société de Dermatologie Française
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant peptide of Human Papilloma Virus (HPV) 16.
In line with this recent work which shows for the first time a link between HPV-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.
Detailed Description
Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant peptide of Human Papilloma Virus (HPV) 16.
In line with this recent work which shows for the first time a link between HPV-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to to test the hypothesis that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.
Regarding erosive lichen planus, the aim is to test the cytotoxic function of the previously identified CD8 T lymphocytes specific for HPV16 E711-20.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with lichen
Arm Type
Experimental
Arm Description
Patients with non-erosive lichen planus, erosive lichen planus or lichen sclerosus.
Human biological samples :
Blood sample
Skin or mucosal brushing
Skin or mucosal biopsy
Intervention Type
Procedure
Intervention Name(s)
Human biological samples
Intervention Description
Blood sample
Skin or mucosal brushing
Skin or mucosal biopsy
Primary Outcome Measure Information:
Title
The use of the different segments of the Vbeta gene assessed by quantitative PCR, and the distribution of the different sizes of the complementarity determining regions (CDR) CDR3 by immunoscope.
Description
In patients with a non-erosive type of lichen and with a lichen sclerosus et atrophicus, the hypothesis for oligoclonal bias in the T-cell receptor repertoire on peripheral and in situ CD4 and CD8 T lymphocytes will be tested realizing, on the 2 sorted subpopulations, a study of the use of the different segments of the Vbeta gene using quantitative Polymerase Chain Reaction (PCR) and a study of the distribution study of the different sizes of the CDR3 using immunoscope method.
Depending on whether or not bias in the T-cell receptor repertoire exists, the study will be continued by looking for the same repertoire bias in situ, on injury site (skin or mucous, depending on the clinical type of lichen), and the research of clonal sequences (or clonotypes) from RNA of patients after cloning and complete sequencing. If clonotype T CD8 Vbeta3 are identified in these types of lichen, their specificity to HPV16 E711-20 wil be assessed by flow cytometry.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes assessed by flow cytometry.
Description
In patients with erosive lichen planus, the functionality and the cytotoxicity of CD8 Vbeta3 peripheric T lymphocytes will be assessed showing their ability to recognize and destroy a target carrier of HPV16 E711-20 peptide by flow cytometry.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 year-old
Clinically or histologically confirmed lichen : Non-erosive lichen planus, Erosive lichen planus, or Sclerosus lichen
At diagnosis of desease before treatment, or during flares of the disease, with or without intake or topical application of immunosuppressants
Affiliated or beneficiary of a social security system
Informed and written consent
Exclusion Criteria:
Under 18 year-old,
Legal protection measures,
Inability to consent
Pregnant or breastfeeding women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Lise Gougeon
Organizational Affiliation
Institut Pasteur
Official's Role
Study Director
Facility Information:
Facility Name
Service de Dermatologie du CHU de Besançon
City
Besançon
Country
France
Facility Name
Service de Dermatologie de l'hôpital Saint Louis
City
Paris
Country
France
Facility Name
Service de Dermatologie du CHU de Reims
City
Reims
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen)
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