NCT06599411招募中不适用
Identification Des Marqueurs Biologiques cutanés et Sanguins prédictifs de réponse Aux Traitements systémiques au Cours Des Maladies cutanées Inflammatoires Chroniques
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 830
- 试验地点
- 1
- 主要终点
- Therapeutic response
研究概览
简要总结
Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases.
The main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases.
The secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age>18 years
- •Informed consent signed by the patient
- •Diagnosis of moderate to severe chronic inflammatory skin disease (IGA score 3 or 4) including: atopic dermatitis, psoriasis, hidradenitis suppurativa, lichen planus, cutaneous lupus, dermatomyositis, cutaneous scleroderma (=morphea), neutrophilic dermatosis, cutaneous granulomatosis, cutaneaous vasculitis, autoimmune bullous dermatosis
- •Or diagnosis of active leprosy (tuberculoid, lepromatous, reversion type 1, reversion type 2, hypersensitivity type 3), excluding pure neurological leprosy. Classification into 5 stages according to the Ridley and Jopling classification [1], Reversion reaction (type 1 reaction) and leprous erythema nodosum (type 2 reaction).
- •Healthy controls :
- •Age>18 years
- •Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants
- •Informed consent signed by the patient
- •Absence of known cutaneous inflammatory disease.
排除标准
- •Under guardianship or curatorship
- •Pregnant or breastfeeding woman
- •Lack of affiliation with a social security system
- •Current systemic treatment with immunosupressant (including corticosteroid therapy) or an immunomodulator or received within the last 3 months.
研究组 & 干预措施
Patients
Affected by inflammatory skin disease
干预措施: Sampling (Other)
Controls
Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants
干预措施: Sampling (Other)
结局指标
主要结局
Therapeutic response
时间窗: At 1 year
It is defined as complete or partial remission on the Investigator/Physician Global Assessment (IGA/PGA) scale.
次要结局
- Expression of markers of blood and skin immunological signaling pathways(At 1 year)
- Expression of markers of blood T cell populations and skin transcriptomics(At 1 year)
- Therapeutic response(At 10 years)
- Microbiota markers(At 1 year)
- Proportion of patients suffering from adverse effects of systemic treatments(At 10 years)
- Quality of life measurement(At 8 years)
- Quality of life measurement(At 9 years)
- Quality of life measurement(At 10 years)
- Expression of markers of blood and skin immunological signaling pathways(At inclusion)
- Expression of markers of blood and skin immunological signaling pathways(At 4 months)
- Expression of markers of blood T cell populations and skin transcriptomics(At inclusion)
- Expression of markers of blood T cell populations and skin transcriptomics(At 4 months)
- Therapeutic response(At inclusion)
- Therapeutic response(At 4 months)
- Therapeutic response(At 1 year)
- Therapeutic response(At 2 years)
- Therapeutic response(At 3 years)
- Therapeutic response(At 4 years)
- Therapeutic response(At 5 years)
- Therapeutic response(At 6 years)
- Therapeutic response(At 7 years)
- Therapeutic response(At 8 years)
- Therapeutic response(At 9 years)
- Microbiota markers(At inclusion)
- Proportion of patients suffering from adverse effects of systemic treatments(At inclusion)
- Proportion of patients suffering from adverse effects of systemic treatments(At 4 months)
- Proportion of patients suffering from adverse effects of systemic treatments(At 1 year)
- Proportion of patients suffering from adverse effects of systemic treatments(At 2 years)
- Proportion of patients suffering from adverse effects of systemic treatments(At 3 years)
- Proportion of patients suffering from adverse effects of systemic treatments(At 4 years)
- Proportion of patients suffering from adverse effects of systemic treatments(At 5 years)
- Quality of life measurement(At 1 year)
- Proportion of patients suffering from adverse effects of systemic treatments(At 6 years)
- Proportion of patients suffering from adverse effects of systemic treatments(At 7 years)
- Proportion of patients suffering from adverse effects of systemic treatments(At 8 years)
- Proportion of patients suffering from adverse effects of systemic treatments(At 9 years)
- Quality of life measurement(At inclusion)
- Quality of life measurement(At 4 months)
- Quality of life measurement(At 2 years)
- Quality of life measurement(At 3 years)
- Quality of life measurement(At 4 years)
- Quality of life measurement(At 5 years)
- Quality of life measurement(At 6 years)
- Quality of life measurement(At 7 years)
研究者
研究点 (1)
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