Study on Variation of Serum and Fecal Biomarkers After Treatment to Predict Mucosal Healing in Patients With Ulcerative Colitis (MIROIR)
연구 개요
상세 설명
Patients with UC requiring endoscopy (colonoscopy or recto sigmoidoscopy) in their management and with endoscopic activity (Mayo endoscopic score ≥ 2) will be offered inclusion in this study.
Blood and faecal samples will be taken in addition to the usual care measurements for the determination of biomarkers under study. Routine care biopsies will be performed in each patient during endoscopy to assess histologic activity.
Because of endoscopic activity, treatment will be changed (start, increase or change treatment) according to current recommendations. After several weeks of treatment (8 ± 4 weeks for 5-ASA and corticosteroids, 12 to 24 weeks for immunosuppressants and 12 ± 2 weeks for biotherapies), patients will have an evaluation performed by endoscopy (colonoscopy or rectosigmoidoscopy) with biopsies for histological analysis (routine care). Blood and faecal samples will be taken in addition to the usual care measurements (blood count, albumin, CRP and faecal calprotectin...) for the determination of biomarkers under study.
Every patient will have a follow-up every 3 months for 1 year with clinical evaluation, blood and faecal biomarker assays and each patient will have a new endoscopic evaluation with biopsies for histological analysis at 12 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Auvergne
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Clermont-Ferrand, Auvergne, 프랑스, 63003
- CHU de Clermont-Ferrand
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients with Ulcerative Colitis
- Age ≥ 18 years
- Presence of endoscopic activity (Mayo endoscopic score ≥ 2) requiring the introduction, increase or change of treatment
- Patients able to consent
Non Inclusion Criteria :
- Patients not affiliated to the social security system
- Pregnant or breastfeeding woman
- Patients who have total coloproctectomy with ileo-anal anastomosis
- Acute Severe Ulcerative Colitis (ASUC)
- Persons under guardianship, trusteeship or imprisonment
Exclusion Criteria:
- Patient wishing to discontinue participation in the study for any reason
- Study exit at the investigator's discretion
- Pregnancy Discovery
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: Patients affected by an ulcerative colitis
Predict mucosal healing in patients with ulcerative colitis by measures on the variation of serum and fecal biomarkers after treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum measurements: CHI3L1 and NGAL-MMP9
기간: Serum change from baseline to month 3
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Measurements in Blood samples
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Serum change from baseline to month 3
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Serum measurements: CHI3L1 and NGAL-MMP9
기간: Serum change from baseline to month 6
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Measurements in Blood samples
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Serum change from baseline to month 6
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Serum measurements: CHI3L1 and NGAL-MMP9
기간: Serum change from baseline to month 9
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Measurements in Blood samples
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Serum change from baseline to month 9
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Serum measurements: CHI3L1 and NGAL-MMP9
기간: Serum change from baseline to month 12
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Measurements in Blood samples
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Serum change from baseline to month 12
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Fecal measurements: CHI3L1, MMP9
기간: Comparison between baseline and month 3
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Measurements in Stool samples
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Comparison between baseline and month 3
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Fecal measurements: CHI3L1, MMP9
기간: Comparison between baseline and month 6
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Measurements in Stool samples
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Comparison between baseline and month 6
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Fecal measurements: CHI3L1, MMP9
기간: Comparison between baseline and month 9
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Measurements in Stool samples
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Comparison between baseline and month 9
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Fecal measurements: CHI3L1, MMP9
기간: Comparison between baseline and month 12
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Measurements in Stool samples
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Comparison between baseline and month 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
기간: Comparison between baseline and month 3
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Mucosal healing defined as Mayo Endoscopic Score ≤1 (Mayo 0 : normal mucosa or inactive disease ; Mayo 1 : mild activity (erythema, decreased vascular pattern, mild friability); Mayo 2 : moderate activity (marked erythema, lack of vascular patterne, friability, erosions); Mayo 3 : severe activity (spontaneus bleeding, large ulcerations)).
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Comparison between baseline and month 3
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Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
기간: Comparison between baseline and month 12
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Mucosal healing defined as Mayo Endoscopic Score ≤1 (Mayo 0 : normal mucosa or inactive disease ; Mayo 1 : mild activity (erythema, decreased vascular pattern, mild friability); Mayo 2 : moderate activity (marked erythema, lack of vascular patterne, friability, erosions); Mayo 3 : severe activity (spontaneus bleeding, large ulcerations)).
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Comparison between baseline and month 12
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Histological Healing Assessed by Geboes Score
기간: Comparison between baseline and month 3
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Comparison between baseline and month 3
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Histological Healing Assessed by Nancy Histological Index
기간: Comparison between baseline and month 3
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Comparison between baseline and month 3
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Histological Healing Assessed by Geboes Score
기간: Comparison between baseline and month 12
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Comparison between baseline and month 12
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Histological Healing Assessed by Nancy Histological Index
기간: Comparison between baseline and month 12
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Comparison between baseline and month 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anthony BUISSON, MD, PhD, - CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CHU-398
- 2017-A02918-45 (기타 식별자: 2017-A02918-45)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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