Literature DB >> 33974994

Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.

Barcey T Levy1, Jeanette M Daly2, Yinghui Xu2, Seth D Crockett3, Richard M Hoffman4, Jeffrey D Dawson5, Kim Parang2, Navkiran K Shokar6, Daniel S Reuland7, Marc J Zuckerman8, Avraham Levin9.   

Abstract

BACKGROUND: 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.
METHODS: A total of 3600 racially and ethnically diverse individuals aged 50 to 85 years 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.
RESULTS: 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.
CONCLUSIONS: 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.
Copyright © 2021 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Clinical trial; Colorectal cancer screening; Comparative effectiveness study; Fecal immunochemical test; Protocol; Test characteristics

Mesh:

Year:  2021        PMID: 33974994      PMCID: PMC8227954          DOI: 10.1016/j.cct.2021.106430

Source DB:  PubMed          Journal:  Contemp Clin Trials        ISSN: 1551-7144            Impact factor:   2.261


  60 in total

1.  Electronic Health Record Algorithm Development for Research Subject Recruitment Using Colonoscopy Appointment Scheduling.

Authors:  Jeanette M Daly; Kim Parang; Barcey T Levy
Journal:  J Am Board Fam Med       Date:  2021 Jan-Feb       Impact factor: 2.657

Review 2.  Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: a consensus statement by the US Multi-Society Task Force on colorectal cancer.

Authors:  Douglas J Robertson; Jeffrey K Lee; C Richard Boland; Jason A Dominitz; Francis M Giardiello; David A Johnson; Tonya Kaltenbach; David Lieberman; Theodore R Levin; Douglas K Rex
Journal:  Gastrointest Endosc       Date:  2016-10-18       Impact factor: 9.427

3.  A systematic comparison of microsimulation models of colorectal cancer: the role of assumptions about adenoma progression.

Authors:  Karen M Kuntz; Iris Lansdorp-Vogelaar; Carolyn M Rutter; Amy B Knudsen; Marjolein van Ballegooijen; James E Savarino; Eric J Feuer; Ann G Zauber
Journal:  Med Decis Making       Date:  2011-06-14       Impact factor: 2.583

4.  Sensitivity and Specificity of Community Fecal Immunotesting Screening for Colorectal Carcinoma in a High-Risk Canadian Population.

Authors:  Amber L Crouse; Lawrence De Koning; S M Hossein Sadrzadeh; Christopher Naugler
Journal:  Arch Pathol Lab Med       Date:  2015-11       Impact factor: 5.534

5.  Cancer and colorectal cancer: knowledge, beliefs, and screening preferences of a diverse patient population.

Authors:  Navrikan K Shokar; Sally W Vernon; Susan C Weller
Journal:  Fam Med       Date:  2005-05       Impact factor: 1.756

6.  Diagnostic accuracy of faecal immunochemical test for screening individuals with a family history of colorectal cancer.

Authors:  S C Ng; J Y L Ching; V Chan; M C S Wong; B Y Suen; H W Hirai; T Y T Lam; J Y W Lau; S S M Ng; J C Y Wu; F K L Chan; J J Y Sung
Journal:  Aliment Pharmacol Ther       Date:  2013-08-20       Impact factor: 8.171

7.  Detection Rate of Colorectal Cancer or Precancer Adenoma by Colonoscopy After 1, 2, or 3 Positive Results via Fecal Immunochemical Testing.

Authors:  Jill A Hancock; Glen A Palmer
Journal:  Lab Med       Date:  2019-07-16

8.  Identification of colorectal adenomas by a quantitative immunochemical faecal occult blood screening test depends on adenoma characteristics, development threshold used and number of tests performed.

Authors:  P Rozen; Z Levi; R Hazazi; A Waked; A Vilkin; E Maoz; S Birkenfeld; M Leshno; Y Niv
Journal:  Aliment Pharmacol Ther       Date:  2009-04-15       Impact factor: 8.171

9.  Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy.

Authors:  Hermann Brenner; Sha Tao
Journal:  Eur J Cancer       Date:  2013-05-22       Impact factor: 9.162

10.  System Strategies for Colorectal Cancer Screening at Federally Qualified Health Centers.

Authors:  Jeanette M Daly; Barcey T Levy; Carol A Moss; Camden P Bay
Journal:  Am J Public Health       Date:  2015-01       Impact factor: 9.308

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  2 in total

1.  Clock-Drawing Test as a Screening Tool for Cognitive Impairment Associated With Fecal Immunochemical Test Collection Errors.

Authors:  Jeanette M Daly; Yinghui Xu; Seth D Crockett; Megan E Schmidt; Peter Kim; Barcey T Levy
Journal:  Ann Fam Med       Date:  2022 Sep-Oct       Impact factor: 5.707

Review 2.  Biomarkers to Detect Early-Stage Colorectal Cancer.

Authors:  Jacqueline I Keenan; Frank A Frizelle
Journal:  Biomedicines       Date:  2022-01-25
  2 in total

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