Copyright
©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
Factors associated with false fecal immunochemical test results in colorectal cancer screening
Shu-Yuan Wang, Xue-Tao Dong, Zhen Yuan, Lei-Xin Jin, Wei-Feng Gao, You-Kui Han, Ke-Min Ni, Zhao-Ce Liu, Jun-Ying Wang, Xiao-Meng Wei, Xiao-Min Su, Xi Peng, Chun-Ze Zhang
Shu-Yuan Wang, Zhen Yuan, Ke-Min Ni, Zhao-Ce Liu, Xiao-Min Su, Xi Peng, School of Medicine, Nankai University, Tianjin 300071, China
Xue-Tao Dong, Department of Gastroenterology, Tianjin Union Medical Center, Tianjin 300121, China
Lei-Xin Jin, School of Integrative Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Wei-Feng Gao, Jun-Ying Wang, Chun-Ze Zhang, Department of Colorectal Surgery, Tianjin Union Medical Center, Tianjin 300121, China
You-Kui Han, Department of General Surgery, Tianjin Union Medical Center, Tianjin 300121, China
Xiao-Meng Wei, Hospital Infection Management Division, Tianjin Union Medical Center, Tianjin 300121, China
Co-first authors: Shu-Yuan Wang and Xue-Tao Dong.
Co-corresponding authors: Xi Peng and Chun-Ze Zhang.
Author contributions: Zhang CZ and Peng X conceived and designed the study and received funding; Zhang CZ, Peng X and Su XM performed data acquisition and collection; Wang SY, Yuan Z and Dong XT did data analysis and interpretations; Wang SY, Jin LX, Gao WF, Han YK and Liu ZC prepared the first draft; Ni KM, Wang JY, Wei XM and Zhang CZ critically revised the manuscript; all authors approved the final manuscript; Wang SY and Dong XT contributed equally to this work as co-first authors. Given the substantial workload involved in data processing and analysis, they collaboratively completed all aspects of the work. Zhang CZ and Peng X contributed equally to this work as co-corresponding authors. They dedicated equal time and effort to the initiation, supervision, and management of the project.
Supported by Natural Science Foundation of Tianjin, No. 21JCZDJC00060 and No. 21JCYBJC00180; Tianjin Health and Medical Science and Technology Project, No. TJWJ2023QN040; and National Key Research and Development Program, No. 2017YFC1700606 and No. 2017YFC1700604.
Institutional review board statement: The study was approved by the Ethics Committee of Tianjin Union Medical Center (Approval No. 2022-803).
Informed consent statement: All participants have signed the informed consent forms.
Conflict-of-interest statement: The authors declare no potential conflict of interests.
Data sharing statement: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Chun-Ze Zhang, MD, PhD, Professor, Department of Colorectal Surgery, Tianjin Union Medical Center, No. 190 Jieyuan Road, Hongqiao District, Tianjin 300121, China.
chunze.zhang@nankai.edu.cn
Received: September 16, 2024
Revised: December 10, 2024
Accepted: January 22, 2025
Published online: April 15, 2025
Processing time: 190 Days and 6.2 Hours
BACKGROUND
Certain subgroups are at an increased risk of false fecal immunochemical test (FIT) results; however, related studies are limited, and the available evidence is conflicting.
AIM
To evaluate factors associated with false-positive and false-negative FIT results.
METHODS
This retrospective study was based on the database of the Tianjin Colorectal Cancer Screening Program from 2012 to 2020. A total of 4129947 residents aged 40-74 years completed at least one FIT. Of these, 24890 asymptomatic participants who underwent colonoscopy examinations and completed lifestyle questionnaires were included in the analysis. Multivariable logistic regression was performed to identify the factors associated with false FIT results.
RESULTS
Among the overall screening population, 88687 (2.15%) participants tested positive for FIT. The sensitivity, specificity, positive predictive value, and negative predictive value of FIT for advanced neoplasms were 58.2%, 44.8%, 9.7%, and 91.3%, respectively. Older age, female sex, smoking, alcohol consumption, higher body mass index, and hemorrhoids were significantly associated with increased odds of false-positive and lower odds of false-negative FIT results. Moreover, features of high-grade dysplasia or villous for advanced adenoma and the presence of cancer were also associated with lower odds of false-negative results, while irregular exercise and diverticulum were associated with higher odds of false-positive results.
CONCLUSION
FIT results may be inaccurate in certain subgroups. Our results provide important evidence for further individualization of screening strategies.
Core Tip: This comprehensive study, encompassing 4129947 participants, uncovers crucial insights into factors associated with false-positive and false-negative results in fecal immunochemical tests (FITs) for colorectal cancer (CRC) screening. It identifies novel risk factors, such as body mass index, exercise habits, and specific tumor characteristics, shedding light on the need for personalized screening strategies. These findings have significant implications for enhancing the accuracy and effectiveness of FIT-based CRC screening programs.
