Case Control Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jan 15, 2023; 15(1): 102-111
Published online Jan 15, 2023. doi: 10.4251/wjgo.v15.i1.102
Diagnostic accuracy of the multi-target stool DNA test in detecting colorectal cancer: A hospital-based study
Han-Lu Gao, Le-Bin Lv, Wang-Fang Zhao, Qi-Wen Lu, Jin-Qing Fan
Han-Lu Gao, Le-Bin Lv, Department of Preventive Health, The Affiliated Hospital of Medical School of Ningbo University, Ningbo, Zhejiang Province, China
Wang-Fang Zhao, Qi-Wen Lu, Department of Gastroenterology, The Affiliated Hospital of Medical School of Ningbo University, Ningbo 315000, Zhejiang Province, China
Jin-Qing Fan, Department of Traditional Chinese Medicine, The Affiliated Hospital of Medical School of Ningbo University, Ningbo 315000, Zhejiang Province, China
Author contributions: Gao HL performed data analysis and wrote the manuscript; Zhao WF and Lu QW participated in the collection of human material; Lv LB performed data collection and collation; Fan JQ designed the study and corrected the manuscript.
Supported by The Health Science and Technology Project of Zhejiang Province, No. 2021KY1048 and No. 2022KY1142; The Ningbo Health Young Technical Backbone Talents Training Program, No. 2020SWSQNGG-02; Key Science and Technology Project of Ningbo City, No. 2021Z133.
Institutional review board statement: The study was approved by the Human Research and Ethics Committee of the Affiliated Hospital of Medical School of Ningbo University (Approval No. KY20201111).
Informed consent statement: Informed written consent was obtained from the patient and her family for publication of this report and any accompanying images.
Conflict-of-interest statement: No conflict of interest exists in the submission of this manuscript.
Data sharing statement: No additional data are available.
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: Jin-Qing Fan, PhD, Doctor, Department of Traditional Chinese Medicine, The Affiliated Hospital of Medical School of Ningbo University, No. 247 Renmin Road, Ningbo 315000, Zhejiang Province, China. 824803804@qq.com
Received: September 17, 2022
Peer-review started: September 17, 2022
First decision: November 18, 2022
Revised: November 19, 2022
Accepted: December 21, 2022
Article in press: December 21, 2022
Published online: January 15, 2023
Processing time: 114 Days and 20.1 Hours
Abstract
BACKGROUND

The multi-target stool DNA test (MT-sDNA) has potential utility in the detection of colorectal cancer (CRC), but validation of its clinical accuracy has been limited in China.

AIM

To evaluate the diagnostic performance of MT-sDNA and investigate the combined diagnostic value of alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and carbohydrate antigen 199 (CA199) with MT-sDNA in CRC and adenomas.

METHODS

We evaluated the performance of the MT-sDNA kit based on a hospital clinical trial. In this case-control study, 135 participants from the Affiliated Hospital of Medical School of Ningbo University, including 51 CRC patients, 23 patients with adenomas, and 61 healthy controls were enrolled. We used a risk scoring system to determine the positivity of tests with histological diagnosis or colonoscopy as the reference standard.

RESULTS

The main indices of sensitivity, specificity and accuracy were evaluated. The sensitivity and specificity for CRC detection were 90.2% and 83.3%, respectively, with an accuracy of 89.8%. For adenoma, the sensitivity and specificity were 56.5% and 68.9%, respectively, with an accuracy of 73.1%. The sensitivity and specificity of MT-sDNA combined with CEA in the diagnosis of adenoma were 78.3% and 60.7%, respectively.

CONCLUSION

The MT-sDNA test showed better performance in the detection of CRC, which was superior to AFP, CEA, and CA199 separately, but not for predicting adenomas. The combination of MT-sDNA with CEA further improved the sensitivity for adenoma diagnosis.

Keywords: Colorectal cancer; MT-sDNA; Cancer diagnosis; Adenoma; Sensitivity; Specificity

Core Tip: The sensitivity and specificity for colorectal cancer (CRC) detection were 90.2% and 83.3%, respectively, with an accuracy of 89.8%. For adenoma, the sensitivity and specificity were 56.5% and 68.9%, respectively, with an accuracy of 73.1%. The multi-target stool DNA (MT-sDNA) test showed better performance for the detection of CRC, which was superior to alpha-fetoprotein, carcinoembryonic antigen (CEA), and carbohydrate antigen 199 separately, but not for predicting adenomas. The sensitivity and specificity of MT-sDNA combined with CEA in the diagnosis of adenoma were 78.3% and 60.7%, respectively, which suggested that combined detection has certain advantages in adenoma diagnosis. This study can help clinicians select a standardized and optimal management strategy for the treatment of these patients.