Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.
Clinical trial
Colorectal cancer screening
Comparative effectiveness study
Fecal immunochemical test
Protocol
Test characteristics
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
07
12
2020
revised:
26
04
2021
accepted:
04
05
2021
pubmed:
12
5
2021
medline:
25
9
2021
entrez:
11
5
2021
Statut:
ppublish
Résumé
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 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.
Sections du résumé
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.
Identifiants
pubmed: 33974994
pii: S1551-7144(21)00166-X
doi: 10.1016/j.cct.2021.106430
pmc: PMC8227954
mid: NIHMS1707573
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03264898']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106430Subventions
Organisme : NCI NIH HHS
ID : P30 CA086862
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA215034
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002537
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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