Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis (DESTIN)
연구 개요
상세 설명
Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.
Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.
Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Clermont-ferrand, 프랑스, 63003
- CHU clermont-ferrand
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Clichy, 프랑스, 92110
- Hopital Beaujon
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Lille, 프랑스
- CHRU Lille
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Nice, 프랑스, 06202
- CHU NICE
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Paris, 프랑스, 75012
- Hôpital Saint-Antoine
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Paris, 프랑스, 75010
- Hopital Saint Louis
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Paris, 프랑스, 75014
- IMM
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Pessac, 프랑스, 33700
- CHU Bordeaux - Pessac
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Toulouse, 프랑스, 31403
- CHU Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female patients over 18 years old
- Active or Inactive Crohn's Disease
- Previously enrolled in RAPID clinical trial
Exclusion Criteria:
- Pregnant or nursing woman
- Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
- Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Evaluation group
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations. All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
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Abdominal MRI to realize within 4 months following inclusion
Upper endoscopy to realize within 4 months following inclusion
Colonoscopy to realize within 4 months following inclusion
Pelvic MRI to realize within 4 months following inclusion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Digestive damage
기간: 5 to 10 years after diagnosis
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Evaluate digestive damage in Crohn's Disease by using Lemann Index
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5 to 10 years after diagnosis
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Predictive factors of the digestive damage evolution
기간: 5 to 10 years after diagnosis
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Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
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5 to 10 years after diagnosis
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Predictive factors of the digestive damage evolution
기간: 5 to 10 years after diagnosis
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Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis.
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5 to 10 years after diagnosis
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Variation of Lemann Index
기간: 5 to 10 years after diagnosis
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Variation of Lemann Index 5 to 10 years after diagnosis
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5 to 10 years after diagnosis
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공동 작업자 및 조사자
수사관
- 수석 연구원: Benjamin Pariente, MD, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- 수석 연구원: Jacques Cosnes, MD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
간행물 및 유용한 링크
일반 간행물
- Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.
- Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panes J, Scholmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lemann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2015-4
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