Journal article
Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: Study protocol
Contemporary clinical trials, Vol.106, pp.106430-106430
05/08/2021
DOI: 10.1016/j.cct.2021.106430
PMCID: PMC8227954
PMID: 33974994
Abstract
There are nearly 50,000 colorectal cancer (CRC) deaths in the United States each year. CRC is curable if detected in its early stages. Fecal immunochemical tests (FITs) can detect precursor lesions and many can be analyzed at the point-of-care (POC) in physician offices. However, there are few data to guide test selection. Broader use of FITs could make CRC screening more accessible, especially in resource-poor settings.
A total of 3600 racially and ethnically diverse individuals aged 50 to 85 years of age having either a screening or surveillance colonoscopy will be recruited. Each participant will complete five FITs on a single stool sample. Test characteristics for each FIT for advanced colorectal neoplasia (ACN) will be calculated using colonoscopy as the gold standard.
We have complete data from a total of 2990 individuals. Thirty percent are Latino and 5.3% are black/African American. We will present full results once the study is completed.
Our focus in this study is how well FITs detect ACN, using colonoscopy as the gold standard. Four of the five FITs being used are POC tests. Although FITs have been shown to have acceptable performance, there is little data to guide which ones have the best test characteristics and colonoscopy is the main CRC screening test used in the United States. Use of FITs will allow broader segments of the population to access CRC screening because these tests require no preparation, are inexpensive, and can be collected in the privacy of one's home. Increasing CRC screening uptake will reduce the burden of advanced adenomas and colorectal cancer.
Details
- Title: Subtitle
- Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: Study protocol
- Creators
- Barcey T Levy - Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America; Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, United States of America; Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, United States of America. Electronic address: barcey-levy@uiowa.eduJeanette M Daly - Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of AmericaYinghui Xu - Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of AmericaSeth D Crockett - Department of Gastroenterology and Hepatology, North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of AmericaRichard M Hoffman - Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, United States of America; Department of Gastroenterology and Hepatology, North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of AmericaJeffrey D Dawson - Department of Biostatistics and Dean's Office, College of Public Health, University of Iowa, Iowa City, IA, United States of AmericaKim Parang - Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of AmericaNavkiran K Shokar - Department of Family and Community Medicine, Texas Tech University Health Sciences Center, El Paso, TX, United States of AmericaDaniel S Reuland - Department of Medicine, Division of General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill, NC, United States of AmericaMarc J Zuckerman - Division of Gastroenterology, Department of Internal Medicine, Texas Tech University Health Sciences Center, El Paso, TX, United States of AmericaAvraham Levin - Department of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.106, pp.106430-106430
- DOI
- 10.1016/j.cct.2021.106430
- PMID
- 33974994
- PMCID
- PMC8227954
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Grant note
- DOI: 10.13039/100006108, name: National Center for Advancing Translational Sciences, award: P30 CA086862, UL1TR002537; DOI: 10.13039/100000002, name: National Institutes of Health; DOI: 10.13039/100000054, name: National Cancer Institute, award: R01 CA215034
- Language
- English
- Date published
- 05/08/2021
- Academic Unit
- Public Health Administration; Epidemiology; Gastroenterology and Hepatology; Biostatistics; Family and Community Medicine; General Internal Medicine; Internal Medicine
- Record Identifier
- 9984214853102771
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