Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort (Early-HS)
Physiopathologie précoce de l'hidradénite suppurée et prédiction du Risque de Progression : Cohorte Prospective
Hidradenitis suppurativa (HS) is a chronic inflammatory disease affecting approximately 1% of the population. Most pathophysiological studies have focused on advanced forms (Hurley II-III), which obscures the initial mechanisms. The mean diagnostic delay of 7 to 10 years and the lack of prognostic biomarkers limit early management. Identifying molecular and microbiological alterations as early as Hurley stage I could allow stratification of the risk of progression and support early intervention strategies.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Charles Cassius
- 电话号码:+33 01 42 49 99 61
- 邮箱:charles.cassius@aphp.fr
研究联系人备份
- 姓名:Jérôme Lambert
- 电话号码:+33 +33142499742
- 邮箱:jerome.lambert@u-paris.fr
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
HS patients:
- Age ≥ 12 years
- Consultation for a recurrent abscess or nodule in an HS area (axillary, inframammary, abdominal, inguinal, perineal, intergluteal and intermammary regions)
- At least one inflammatory lesional area accessible to biopsy outside skin folds and the face. A fold is defined as the area within 1 cm of the crease.
- First episode within the past 12 months
- Free, informed, written and signed consent (adult patient, or holders of parental authority + assent of the minor)
- Affiliation to a social security scheme
Controls:
- Healthy control enrolled in the ImmuneSkinBank research protocol coordinated by the same investigating team (IDRC 2024-A00202-45, APHP240183, favourable opinion from CPP Sud-Méditerranée II), who agreed to the reuse of their data and samples for future research.
- Matched to an HS patient on age (by age group) and sex
- Informed about the study by an information notice sent by post
Exclusion Criteria:
HS patients:
-
Buttock involvement
-
HS-related sinus tracts (Hurley II or III)
-
Treatment that may interfere with the course of HS:
- Long-term antibiotic therapy received within the past month
- Immunosuppressive/immunomodulatory treatment within the past 3 months
-
Person under guardianship or curatorship, under judicial protection, or deprived of liberty by judicial or administrative decision
-
Patients covered by State Medical Aid (AME)
-
Pregnant or breastfeeding women
Controls:
Objection to the research
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Patients with HS
Adolescent (≥ 12 years) and adult patients with Hurley stage I HS, presenting with a recurrent nodule or abscess (≥ 2 episodes within 12 months) in characteristic locations. |
|
|
其他:Controls
Healthy subjects matched 1:1 on age (by age group) and sex, recruited among plastic surgery patients with residual skin tissue (e.g. abdominoplasty, breast reduction) enrolled in the ImmuneSkinBank protocol coordinated by the same investigating team (IDRC 2024-A00202-45, NCT06599411, APHP240183). |
e.g. abdominoplasty, breast reduction |
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 |
|---|---|---|
|
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa
大体时间:At inclusion
|
|
At inclusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival to Hurley stage II-III
大体时间:Up to 96 months
|
Time from HS diagnosis to the date of progression to Hurley stage II-III |
Up to 96 months
|
|
Incidence rate of progression to Hurley stage II-III
大体时间:Up to 96 months
|
expressed per 100 person-years of follow-up |
Up to 96 months
|
|
Number of newly involved anatomical regions during follow-up
大体时间:Up to 96 months
|
Analysis of topographic extension |
Up to 96 months
|
|
Proportion of patients in need for major surgery (wide excision, extensive deroofing) and survival free of major surgery
大体时间:Up to 96 months
|
time from HS diagnosis to the first surgical procedure |
Up to 96 months
|
|
Change in IHS4 during follow-up
大体时间:Up to 96 months
|
absolute and relative change from inclusion at each annual visit |
Up to 96 months
|
|
Change in HS-PGA during follow-up
大体时间:Up to 96 months
|
absolute and relative change from inclusion at each annual visit |
Up to 96 months
|
|
Rate of inflammatory flares per year of follow-up
大体时间:Up to 96 months
|
Up to 96 months
|
|
|
Patient-reported score - Dermatology Life Quality Index
大体时间:Up to 96 months
|
The Dermatology Life Quality Index (DLQI) total score ranges from 0 to 30, with higher scores indicating a greater negative impact of the skin disease on quality of life (0-1: no effect; 2-5: small effect; 6-10: moderate effect; 11-20: very large effect; 21-30: extremely large effect). The Children's Dermatology Life Quality Index (CDLQI) total score ranges from 0 to 30, with higher scores indicating a greater negative impact of the skin disease on the child's quality of life. |
Up to 96 months
|
|
Patient-reported score - HiSQOL
大体时间:Up to 96 months
|
The Hidradenitis Suppurativa Quality of Life (HiSQOL) total score ranges from 0 to 68, with higher scores indicating a greater impact of hidradenitis suppurativa on quality of life. Les seuils publiés récemment sont : 0-4 none, 5-14 mild, 15-21 moderate, 22-23 severe, ≥24 very severe. |
Up to 96 months
|
|
Patient-reported score - VAS
大体时间:Up to 96 months
|
Pain intensity is assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
Up to 96 months
|
|
Patient-reported score - HADS/ADRS
大体时间:Up to 96 months
|
The Hospital Anxiety and Depression Scale (HADS) comprises two subscales, HADS-A for anxiety and HADS-D for depression, each ranging from 0 to 21. For each subscale, higher scores indicate greater symptom burden; scores of 0-7 indicate no significant symptoms, 8-10 borderline/doubtful symptoms, and 11-21 probable/significant symptoms. The Adolescent Depression Rating Scale (ADRS) self-report score ranges from 0 to 10, with higher scores indicating a higher risk of depressive symptoms. |
Up to 96 months
|
|
Patient-reported score - AUDIT-C
大体时间:Up to 96 months
|
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score ranges from 0 to 12, with higher scores indicating greater levels of potentially hazardous alcohol consumption. |
Up to 96 months
|
|
Patient-reported score - IPAQ - Short Form
大体时间:Up to 96 months
|
Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ) and expressed in MET-minutes/week; higher values indicate greater physical activity. Physical activity may also be classified as low, moderate or high. |
Up to 96 months
|
|
Patient-reported score - EPICES
大体时间:Up to 96 months
|
Socioeconomic deprivation is assessed using the EPICES score, with higher scores indicating greater socioeconomic deprivation; a score ≥30.17 is commonly used to identify socioeconomic deprivation. |
Up to 96 months
|
|
Patient-reported score - Short FFQ
大体时间:Up to 96 months
|
Food Frequency Questionnaires |
Up to 96 months
|
|
Incidence rate of inflammatory and metabolic comorbidities during follow-up
大体时间:Up to 96 months
|
Up to 96 months
|
|
|
Molecular and microbiological signatures differentially expressed over time within the same HS patient
大体时间:Up to 96 months
|
Up to 96 months
|
|
|
Keratinocyte marker gene expression in skin biopsy and tape stripping
大体时间:At inclusion
|
At inclusion
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- APHP260139
计划个人参与者数据 (IPD)
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