Study on Variation of Serum and Fecal Biomarkers After Treatment to Predict Mucosal Healing in Patients With Ulcerative Colitis (MIROIR)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Auvergne
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Clermont-Ferrand、Auvergne、フランス、63003
- CHU de Clermont-Ferrand
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：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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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 |
|---|---|---|
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Serum measurements: CHI3L1 and NGAL-MMP9
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Comparison between baseline and month 12
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Comparison between baseline and month 12
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協力者と研究者
捜査官
- 主任研究者：Anthony BUISSON, MD, PhD、- CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
キーワード
その他の研究ID番号
- CHU-398
- 2017-A02918-45 (その他の識別子：2017-A02918-45)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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