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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Charles Cassius
- 電話番号：+33 01 42 49 99 61
- メール：charles.cassius@aphp.fr
研究連絡先のバックアップ
- 名前：Jérôme Lambert
- 電話番号：+33 +33142499742
- メール：jerome.lambert@u-paris.fr
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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. |
|
|
他の：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa
時間枠：At inclusion
|
|
At inclusion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival to Hurley stage II-III
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 96 months
|
time from HS diagnosis to the first surgical procedure |
Up to 96 months
|
|
Change in IHS4 during follow-up
時間枠：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
時間枠：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
時間枠：Up to 96 months
|
Up to 96 months
|
|
|
Patient-reported score - Dermatology Life Quality Index
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 96 months
|
Food Frequency Questionnaires |
Up to 96 months
|
|
Incidence rate of inflammatory and metabolic comorbidities during follow-up
時間枠：Up to 96 months
|
Up to 96 months
|
|
|
Molecular and microbiological signatures differentially expressed over time within the same HS patient
時間枠：Up to 96 months
|
Up to 96 months
|
|
|
Keratinocyte marker gene expression in skin biopsy and tape stripping
時間枠：At inclusion
|
At inclusion
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- APHP260139
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