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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Charles Cassius
- 전화번호: +33 01 42 49 99 61
- 이메일: charles.cassius@aphp.fr
연구 연락처 백업
- 이름: Jérôme Lambert
- 전화번호: +33 +33142499742
- 이메일: jerome.lambert@u-paris.fr
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
다른: 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. |
|
|
다른: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa
기간: At inclusion
|
|
At inclusion
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free survival to Hurley stage II-III
기간: 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
기간: 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
기간: 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
기간: Up to 96 months
|
time from HS diagnosis to the first surgical procedure |
Up to 96 months
|
|
Change in IHS4 during follow-up
기간: 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
기간: 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
기간: Up to 96 months
|
Up to 96 months
|
|
|
Patient-reported score - Dermatology Life Quality Index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 96 months
|
Food Frequency Questionnaires |
Up to 96 months
|
|
Incidence rate of inflammatory and metabolic comorbidities during follow-up
기간: Up to 96 months
|
Up to 96 months
|
|
|
Molecular and microbiological signatures differentially expressed over time within the same HS patient
기간: Up to 96 months
|
Up to 96 months
|
|
|
Keratinocyte marker gene expression in skin biopsy and tape stripping
기간: At inclusion
|
At inclusion
|
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추가 정보
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추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- APHP260139
개별 참가자 데이터(IPD) 계획
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