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Идёт набор NCT06451744

Cellular and Molecular Biomarkers in Patients With Lichen Planus

Без фазы С лечением Lichen Planus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Blood samples collection, Skin or mucous membrane brushing, Skin or mucous membrane biopsy.
Кому может быть актуально
Состояния в реестре: Lichen Planus. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Identification of TCR repertoire by flow cytometry [Срок оценки: 3 years]
Вторичные конечные точки (2)
  • Identification of characteristic biomarkers of lichen [Срок оценки: 3 years]
  • Identification of T CD8 clonotypes [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 6 центров
  • 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

Идентификаторы

NCT: NCT06451744 · 2021-048

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗