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).
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 2K5
- GI Research Institute (GIRI)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of time that Fecal Calprotectin result caused the physician to change the management of a patient.
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Brian Bressler, MD、Department of Medicine, Division of Gastroenterology, UBC
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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