FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD) (FOCUS)
FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of IBD
Hypothesis:
Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to colonoscopy in the management of patients with Inflammatory Bowel Disease.
Objectives:
By means of a survey from the ordering physician we would assess:
Primary Endpoint
1. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient.
Secondary Endpoints
- To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
- To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
- To assess the correlation between the Fecal Calprotectin level and symptoms as measured by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if endoscopy was performed).
調査の概要
詳細な説明
Patients will be identified as eligible by the attending Gastroenterologist during the course of a usual consultation. Patients will be referred to the research nurse in the doctor's office for further information regarding the study and informed consent will be obtained by the research nurse.
Upon enrollment, the physician or the research nurse will complete an online requisition form with a unique code which will provide the baseline data. The patient will be provided with the Easy Sampler™ collection kit and instructions on the use of this kit and location on where to send the specimen.
The nurse will then send an email to the research nurse in the originating physician's office with the result of the calprotectin assay. The research nurse will review the result with the physician. After physician review, either the physician or the research nurse will then complete a follow up survey online.
After completion of the assays and surveys, the data will be tabulated electronically from the online website and analyzed by the PI and/or co-investigators.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V6Z 2K5
- GI Research Institute (GIRI)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Subjects must be at least 19 years of age or older, they must be able to read and provide written consent in English.
Subjects will have gastrointestinal symptoms or be known to have Inflammatory Bowel Disease whereby the clinician feels that obtaining Fecal Calprotectin may be useful in the care of the patient. Patients must be able to collect a feces sample and return it for analysis within 3 days
Exclusion Criteria:
- Known Ischemic colitis, infectious enteritis or colitis, known colorectal cancer, history of extensive bowel resection, ostomy, current daily use of NSAIDs (aspirin, ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3 days
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
コホートと介入
グループ/コホート |
|---|
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Inflammatory Bowel Disease
Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)
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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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Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient.
時間枠：one year
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The utility of the test will be assessed by comparing the proportion of time the test altered management for each of the two groups (IBD present vs. IBD absent).
The groups will be compared using paired t-tests and McNemar's test as appropriate.
Multivariate analysis will be used to assess the impact of the baseline variables on the test utility.
|
one year
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協力者と研究者
捜査官
- 主任研究者：Brian Bressler, MD、Department of Medicine, Division of Gastroenterology, UBC
出版物と役立つリンク
一般刊行物
- Sutherland AD, Gearry RB, Frizelle FA. Review of fecal biomarkers in inflammatory bowel disease. Dis Colon Rectum. 2008 Aug;51(8):1283-91. doi: 10.1007/s10350-008-9310-8. Epub 2008 Jun 10.
- Gisbert JP, Bermejo F, Perez-Calle JL, Taxonera C, Vera I, McNicholl AG, Algaba A, Lopez P, Lopez-Palacios N, Calvo M, Gonzalez-Lama Y, Carneros JA, Velasco M, Mate J. Fecal calprotectin and lactoferrin for the prediction of inflammatory bowel disease relapse. Inflamm Bowel Dis. 2009 Aug;15(8):1190-8. doi: 10.1002/ibd.20933.
- Schoepfer AM, Beglinger C, Straumann A, Trummler M, Vavricka SR, Bruegger LE, Seibold F. Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn's disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol. 2010 Jan;105(1):162-9. doi: 10.1038/ajg.2009.545. Epub 2009 Sep 15.
- Keohane J, O'Mahony C, O'Mahony L, O'Mahony S, Quigley EM, Shanahan F. Irritable bowel syndrome-type symptoms in patients with inflammatory bowel disease: a real association or reflection of occult inflammation? Am J Gastroenterol. 2010 Aug;105(8):1788, 1789-94; quiz 1795. doi: 10.1038/ajg.2010.156. Epub 2010 Apr 13.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。