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皮肤和血液生物标志物的鉴定可预测慢性炎症性皮肤病期间全身治疗的反应 (ImmuneSkinBank)

2026年6月10日 更新者：Assistance Publique - Hôpitaux de Paris

皮肤生物学鉴定和慢性皮肤炎症反应辅助治疗系统的预测

慢性炎症性皮肤病构成一组异质的病理学。 它们不仅影响皮肤，还影响其他器官（关节、肺、肌肉等）。 他们的预后和对治疗的反应差异很大。 预后因素的发现将有助于根据个体标志物精确指导治疗方案及其强化治疗。 确定新的治疗靶点对于开发炎症性皮肤病的创新疗法至关重要。

主要目标是确定与炎症性皮肤病 1 年治疗反应相关的新细胞或分子预后因素。

次要目标是更好地了解慢性炎症性皮肤病的病理生理学，识别与 10 年演变后的临床状态相关的新的细胞、分子和微生物预后因素，以及识别药物毒性的预后标志物。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

830

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Paris、法国
        • 招聘中
        • Hopital Saint Louis
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

受炎症性皮肤病影响的患者和对照

描述

纳入标准：

患者：

  • 年龄>18岁
  • 患者签署的知情同意书
  • 诊断中度至重度慢性炎症性皮肤病（IGA 评分 3 或 4），包括：特应性皮炎、牛皮癣、化脓性汗腺炎、扁平苔藓、皮肤狼疮、皮肌炎、皮肤硬皮病（=硬斑病）、中性粒细胞性皮肤病、皮肤肉芽肿病
  • 或诊断为活动性麻风病（结核样、麻风病、1 型回复、2 型回复、3 型超敏反应），排除单纯神经性麻风。 根据Ridley和Jopling分类[1]分为5个阶段，逆转反应（1型反应）和麻风结节性红斑（2型反应）。

健康控制：

  • 年龄>18岁
  • 接受过任何类型手术后留下健康皮肤的整形手术患者
  • 患者签署的知情同意书
  • 没有已知的皮肤或全身炎症性疾病。

排除标准：

  • 在监护或监管下
  • 孕妇或哺乳期妇女
  • 缺乏社会保障体系的隶属关系
  • 正在进行或少于 3 个月前接受的全身治疗。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
患者
受到炎症性皮肤病的影响
其他：Sampling
Collection of an additional volume of blood, Superficial skin biopsy, Skin swab, Hair follicle, Stool,
其他：Sampling
Collection of an additional volume of blood, Preservation of post-operative skin remnants, Skin swab, Hair follicle, Stool
控制
接受过任何类型手术后留下健康皮肤的整形手术患者
其他：Sampling
Collection of an additional volume of blood, Superficial skin biopsy, Skin swab, Hair follicle, Stool,
其他：Sampling
Collection of an additional volume of blood, Preservation of post-operative skin remnants, Skin swab, Hair follicle, Stool

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
治疗反应
大体时间：1 年时
它被定义为研究者/医生总体评估 (IGA/PGA) 量表的完全或部分缓解。
1 年时

次要结果测量

结果测量
措施说明
大体时间
血液和皮肤免疫信号通路标志物的表达
大体时间：纳入时
主要是Th1、Th2、Th9、Th17、Th22和Treg
纳入时
血液和皮肤免疫信号通路标志物的表达
大体时间：4个月大时
主要是Th1、Th2、Th9、Th17、Th22和Treg
4个月大时
血液和皮肤免疫信号通路标志物的表达
大体时间：1 年时
主要是Th1、Th2、Th9、Th17、Th22和Treg
1 年时
血液 T 细胞群标记物的表达和皮肤转录组学
大体时间：纳入时
纳入时
血液 T 细胞群标记物的表达和皮肤转录组学
大体时间：4个月大时
4个月大时
血液 T 细胞群标记物的表达和皮肤转录组学
大体时间：1 年时
1 年时
治疗反应
大体时间：纳入时
基于血液 T 细胞群标记和皮肤转录组学
纳入时
治疗反应
大体时间：4个月大时
基于血液 T 细胞群标记和皮肤转录组学
4个月大时
治疗反应
大体时间：1 年时
基于血液 T 细胞群标记和皮肤转录组学
1 年时
治疗反应
大体时间：2岁时
基于血液 T 细胞群标记和皮肤转录组学
2岁时
治疗反应
大体时间：3岁时
基于血液 T 细胞群标记和皮肤转录组学
3岁时
治疗反应
大体时间：4岁时
基于血液 T 细胞群标记和皮肤转录组学
4岁时
治疗反应
大体时间：5岁时
基于血液 T 细胞群标记和皮肤转录组学
5岁时
治疗反应
大体时间：6岁时
基于血液 T 细胞群标记和皮肤转录组学
6岁时
治疗反应
大体时间：7岁时
基于血液 T 细胞群标记和皮肤转录组学
7岁时
治疗反应
大体时间：8岁时
基于血液 T 细胞群标记和皮肤转录组学
8岁时
治疗反应
大体时间：9岁时
基于血液 T 细胞群标记和皮肤转录组学
9岁时
治疗反应
大体时间：10岁时
基于血液 T 细胞群标记和皮肤转录组学
10岁时
微生物群标记
大体时间：纳入时

鉴定特定于病理学的簇，鉴定一种或多种微生物物种的过度代表性。

对于患者和对照
纳入时
微生物群标记
大体时间：1 年时

鉴定特定于病理学的簇，鉴定一种或多种微生物物种的过度代表性。

仅供患者使用
1 年时
遭受全身治疗不良反应的患者比例
大体时间：纳入时
根据CTCAE分类和MedDRA
纳入时
遭受全身治疗不良反应的患者比例
大体时间：4个月大时
根据CTCAE分类和MedDRA
4个月大时
遭受全身治疗不良反应的患者比例
大体时间：1 年时
根据CTCAE分类和MedDRA
1 年时
遭受全身治疗不良反应的患者比例
大体时间：2岁时
根据CTCAE分类和MedDRA
2岁时
遭受全身治疗不良反应的患者比例
大体时间：3岁时
根据CTCAE分类和MedDRA
3岁时
遭受全身治疗不良反应的患者比例
大体时间：4岁时
根据CTCAE分类和MedDRA
4岁时
遭受全身治疗不良反应的患者比例
大体时间：5岁时
根据CTCAE分类和MedDRA
5岁时
遭受全身治疗不良反应的患者比例
大体时间：6岁时
根据CTCAE分类和MedDRA
6岁时
遭受全身治疗不良反应的患者比例
大体时间：7岁时
根据CTCAE分类和MedDRA
7岁时
遭受全身治疗不良反应的患者比例
大体时间：8岁时
根据CTCAE分类和MedDRA
8岁时
遭受全身治疗不良反应的患者比例
大体时间：9岁时
根据CTCAE分类和MedDRA
9岁时
遭受全身治疗不良反应的患者比例
大体时间：10岁时
根据CTCAE分类和MedDRA
10岁时
Quality of life measurement
大体时间：At inclusion

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At inclusion
Quality of life measurement
大体时间：At 4 months

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 4 months
Quality of life measurement
大体时间：At 1 year

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 1 year
Quality of life measurement
大体时间：At 2 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 2 years
Quality of life measurement
大体时间：At 3 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 3 years
Quality of life measurement
大体时间：At 4 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 4 years
Quality of life measurement
大体时间：At 5 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 5 years
Quality of life measurement
大体时间：At 6 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 6 years
Quality of life measurement
大体时间：At 7 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 7 years
Quality of life measurement
大体时间：At 8 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 8 years
Quality of life measurement
大体时间：At 9 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 9 years
Quality of life measurement
大体时间：At 10 years

The EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability.

The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.
At 10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assistance Publique - Hôpitaux de Paris

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月20日

初级完成 (估计的)

2035年11月20日

研究完成 (估计的)

2045年10月20日

研究注册日期

首次提交

2024年9月13日

首先提交符合 QC 标准的

2024年9月16日

首次发布 (实际的)

2024年9月19日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • APHP240183

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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