자가면역 및 염증 환자를 위한 진단, 예후 및 치료 결정 도구의 개념 (ATRACTion)
The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Primary Immune deficiencies (PIDs) are a group of monogenic diseases related to developmental or functional dysfunction of one or several immune cell types. Individually there are rare entities, but collectively they group several thousands of patients.
Approximately 500 000 patients suffer from PIDs worldwide, making their management a true health-care concern. According to European Society for Immunodeficiencies (ESID), the age group in which PIDs is most frequently diagnosed is under 19 years of age (62%)1. PIDs are causing susceptibility to severe and life-threatening infections by common pathogens, but they also predispose to cancer and can initially manifest as autoimmune and inflammatory diseases.
Multiple mechanisms underlie the development of autoimmunity/inflammation in PIDs. Moreover, their development can be influenced by the composition of the microbiota, which shapes host metabolic and immune functions and can be modified by many environmental factors. In the last two decades a particular emphasis was given to the elucidation of the genomic mutations causing PIDs. This led to a burst of genetic diagnosis as the numbers of known monogenic causes of PIDs rose from around 200 in 2010 to more than 310 in 2017. These genomic approaches revealed that: 1) a given monogenic defect can lead to very dissimilar clinical presentations, disproving the initial concept that a monogenic defect is associated with specific clinical manifestations ; and 2) the number of cases of autosomal dominant genetic deficiencies has increased, with sometimes a partial clinical penetrance so that some relatives carrying the causal genetic variant remain asymptomatic. Hence, onset and presentation of autoimmune and inflammatory diseases in PIDs is highly unpredictable.
PIDs with autoimmunity/inflammation usually require life-long symptomatic treatments including broad immunosuppression or immunotherapies. On the long term, such treatments can have important side effects or poor efficacy and they result in high burden cost. It is therefore crucial to diagnose PIDs as early as possible in order to select the most efficient therapy based not only on clinical features as it is nowadays, but to include the underlying molecular cause of immune dysregulation.
The central goal of this project is to explain the very variable outcome of monogenic autoimmune and inflammatory diseases and to define predictive biomarkers in order to stratify patients and to optimize therapeutic choices.
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
연구 장소
-
-
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Paris, 프랑스
- hôpital Necker Enfants Malades
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with PIDs and autoimmunity/inflammation related to known and unknown genetic defects (ALPS, Cytopenia, Enteropathy-IBD, pSLE, JIA, FHL, CA-EBV, CID) and their healthy relatives (controls) will be recruited in 2 clinical services of Necker hospital: Paediatric Rhumatology Immuno Hematology department Department, and paediatric Paediatric Gastroenterology department Department.
Unrelated controls will be recruited in the Paediatric Rhumatology Immuno Hematology Department, the Paediatric Gastroenterology Department,also be recruited in the Department of Paediatric Visceral and Urologic Surgery and the Department of Maxillofacial Surgery and Paediatric Plastic Surgery within patients hospitalised for a surgery and not affected by an immune-related disease or a cancer.
설명
Inclusion Criteria for controls (patients relatives and unrelated subjects):
- Individuals aged<18 y/o.
- Individuals > 6 kg
- Individuals not affected by an immune-related disease or not affected by cancer
- Individuals whose parents have signed an enlightened consent.
Inclusion criteria for patients
- Individuals with health insurance.
- Patients treated at Necker hospital with PIDs and autoimmunity/inflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and/or Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.
- Individuals aged<18 y/o.
- Individuals > 9 kg
- Patients whose parents have signed an enlightened consent.
Exclusion Criteria:
- Intake of antibiotics within 2 weeks prior inclusion
- Absence of parent's or child consent form
- Cytotoxic cancer treatments
- antiviral treatments (HIV, hepatitis …)
- Short term life-threatening conditions
- Individuals placed under judicial protection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Patients
based on the potential for inclusion of patient's cohort followed in Necker hospital with PIDs and poly-autoimmunity related to known genetic defects. Recruitments will be made at Pediatric Rheumatology Immuno Hematology department, and paediatric Gastroenterology department (n=250). Collection of blood, urine and stools at inclusion and blood at 12 months consultation/ follow-up. |
Blood, Urine and Stool samples will be collected from the participants. |
|
Patients' relatives (control)
Brothers or sisters of the patients (n=125). Collection of blood, urine and stools at inclusion. |
Blood, Urine and Stool samples will be collected from the participants. |
|
Patients with unrelated diseases (control)
Recruitments will be made at the Paediatric Gastroenterology Department, in the Department of Paediatric Visceral and Urologic Surgery and the Department of Maxillofacial Surgery and Paediatric Plastic Surgery at Necker's Hospital. Participants will be included if not diagnosed PIDs and poly-autoimmunity (n=125). Collection of blood, urine and stools. |
Blood, Urine and Stool samples will be collected from the participants. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Generate a diagnosis and therapeutic-decision tools
기간: 5 years
|
Identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomic, epigenomics, proteomic, metagenomic, metabolomics and lipidomics). |
5 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1- Development of an atlas of molecular interactions leading to autoimmunity and inflammation
기간: 5 years
|
Research tool integrating transcriptomic, proteomic, epigenetic, metabolomic and lipidomics data of pediatric affected patients as well as healthy pediatric individuals This atlas will be available widely to the public and private research community. |
5 years
|
|
2 - To develop an artificial intelligent online application
기간: 5 years
|
The decision support tool will be interoperable with any clinical information system and will be clinically validated. |
5 years
|
|
3- Ancillary study (pilot study)
기간: 5 years
|
i. Validation of candidate biomarkers associated to diagnosis and prognosis of Juvenile Idiopathic Arthritis patients ; ii. Definition of a specific clinical outcome and early quantification of the performance of a diagnostic decision tool based on omics signatures (proof of concept) |
5 years
|
공동 작업자 및 조사자
스폰서
스폰서
수사관
수사관
- 수석 연구원: Frédéric Rieux-Laucat, Institut Imagine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 혈구감소증
- 내분비계 질환
- 근골격계 질환
- 병리학적 과정
- 관절염
- 관절 질환
- 류마티스 질환
- 유전병, 선천적
- 대사 질환
- 결합 조직 질환
- 면역계 질환
- 소화기계 질환
- 출혈
- 포도당 대사 장애
- 진성 당뇨병
- 피부 증상
- 혈액 질환
- 간 질환
- 면역 결핍 증후군
- 림프계 질환
- 림프 증식 장애
- 면역증식성 장애
- 혈액 응고 장애
- 출혈성 장애
- 혈소판 장애
- 혈전성 미세혈관병증
- 만성 간염
- 자반병, 혈소판감소증
- 퍼푸라
- 조직구증, 비랑게르한스세포
- 조직구증
- 간염
- 혈소판감소증
- 선천성, 유전성, 신생아 질환 및 이상
- 병리학적 상태, 징후 및 증상
- 영양 및 대사 질환
- 피부 및 결합 조직 질환
- 징후 및 증상
- 헴 및 림프병
- 원발성 면역결핍 질환
- 관절염, 청소년
- 전신성 홍반성 루푸스
- 제1형 당뇨병
- 자반병, 혈소판감소증, 특발성
- 자가면역질환
- 림프조직구증, 혈구포식
- 간염, 자가면역
- 자가면역 림프증식성 증후군
- 다내분비병증, 자가면역
- 자가 면역 장포증
기타 연구 ID 번호
기타 연구 ID 번호
- C20-59
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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