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Showing content from https://pubmed.ncbi.nlm.nih.gov/37576863/ below:

Clinical evaluation of a multitarget fecal immunochemical test-sDNA test for colorectal cancer screening in a high-risk population: a prospective, multicenter clinical study

doi: 10.1002/mco2.345. eCollection 2023 Aug. Clinical evaluation of a multitarget fecal immunochemical test-sDNA test for colorectal cancer screening in a high-risk population: a prospective, multicenter clinical study Xiao-Feng Chen², Chun-Bao Zhai³, Xiao-Tian Yu⁴, Gang Liu⁵, Zhi-Guo Xiong^{6 7}, Zi-Qiang Wang⁸, San-Jun Cai⁹, Wen-Cai Li¹⁰, Xiang-Xing Kong¹, Qian Xiao¹, Cai-Hua Wang¹¹, Zhi-Hua Tao¹², Li-Yun Niu³, Jian-Long Men⁵, Qing Wang⁵, Shao-Zhong Wei^{6 7}, Jun-Jie Hu^{6 7}, Ting-Han Yang⁸, Jun-Jie Peng⁹, Guo-Zhong Jiang¹⁰, Ning Lv⁴, Yi-You Chen⁴, Shu Zheng¹³, Yan-Hong Gu², Ke-Feng Ding^{1 14 15 16}

Affiliations

¹ Department of Colorectal Surgery and Oncology (Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Key Laboratory of Molecular Biology in Medical Sciences, Zhejiang Province, China) The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China.
² Department of Oncology The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital) Nanjing China.
³ Department of Anorectal Surgery Shanxi Provincial People's Hospital Taiyuan China.
⁴ Hangzhou New Horizon Health Technology Co., Ltd. Hangzhou China.
⁵ Department of General Surgery Tianjin Medical University General Hospital Tianjin China.
⁶ Department of Gastrointestinal surgery Hubei Cancer Hospital Wuhan China.
⁷ Colorectal Cancer Medical Research Center of Hubei Wuhan China.
⁸ Department of Gastrointestinal Surgery West China Hospital of Sichuan University Chengdu China.
⁹ Department of Colorectal Surgery Fudan University Shanghai Cancer Center Shanghai China.
¹⁰ Department of Pathology The First Affiliated Hospital of Zhengzhou University Zhengzhou China.
¹¹ Department of Gastroenterology The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China.
¹² Department of Clinical Laboratory The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China.
¹³ Cancer Institute, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China.
¹⁴ Center for Medical Research and Innovation in Digestive System Tumors Hangzhou China.
¹⁵ Zhejiang Provincial Clinical Research Center for CANCER Hangzhou China.
¹⁶ Cancer Center of Zhejiang University Hangzhou China.

PMID: 37576863
PMCID: PMC10422070
DOI: 10.1002/mco2.345

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Clinical evaluation of a multitarget fecal immunochemical test-sDNA test for colorectal cancer screening in a high-risk population: a prospective, multicenter clinical study

Ye-Ting Hu et al. MedComm (2020). 2023.

doi: 10.1002/mco2.345. eCollection 2023 Aug. Authors Ye-Ting Hu¹, Xiao-Feng Chen², Chun-Bao Zhai³, Xiao-Tian Yu⁴, Gang Liu⁵, Zhi-Guo Xiong^{6 7}, Zi-Qiang Wang⁸, San-Jun Cai⁹, Wen-Cai Li¹⁰, Xiang-Xing Kong¹, Qian Xiao¹, Cai-Hua Wang¹¹, Zhi-Hua Tao¹², Li-Yun Niu³, Jian-Long Men⁵, Qing Wang⁵, Shao-Zhong Wei^{6 7}, Jun-Jie Hu^{6 7}, Ting-Han Yang⁸, Jun-Jie Peng⁹, Guo-Zhong Jiang¹⁰, Ning Lv⁴, Yi-You Chen⁴, Shu Zheng¹³, Yan-Hong Gu², Ke-Feng Ding^{1 14 15 16} Affiliations

¹ Department of Colorectal Surgery and Oncology (Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, Key Laboratory of Molecular Biology in Medical Sciences, Zhejiang Province, China) The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China.
² Department of Oncology The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital) Nanjing China.
³ Department of Anorectal Surgery Shanxi Provincial People's Hospital Taiyuan China.
⁴ Hangzhou New Horizon Health Technology Co., Ltd. Hangzhou China.
⁵ Department of General Surgery Tianjin Medical University General Hospital Tianjin China.
⁶ Department of Gastrointestinal surgery Hubei Cancer Hospital Wuhan China.
⁷ Colorectal Cancer Medical Research Center of Hubei Wuhan China.
⁸ Department of Gastrointestinal Surgery West China Hospital of Sichuan University Chengdu China.
⁹ Department of Colorectal Surgery Fudan University Shanghai Cancer Center Shanghai China.
¹⁰ Department of Pathology The First Affiliated Hospital of Zhengzhou University Zhengzhou China.
¹¹ Department of Gastroenterology The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China.
¹² Department of Clinical Laboratory The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China.
¹³ Cancer Institute, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China.
¹⁴ Center for Medical Research and Innovation in Digestive System Tumors Hangzhou China.
¹⁵ Zhejiang Provincial Clinical Research Center for CANCER Hangzhou China.
¹⁶ Cancer Center of Zhejiang University Hangzhou China.

PMID: 37576863
PMCID: PMC10422070
DOI: 10.1002/mco2.345

Item in Clipboard

Abstract

Colorectal cancer (CRC) is a major malignancy threatening the health of people in China and screening could be effective for preventing the occurrence and reducing the mortality of CRC. We conducted a multicenter, prospective clinical study which recruited 4,245 high-risk CRC individuals defined as having positive risk-adapted scores or fecal immunochemical test (FIT) results, to evaluate the clinical performance of the multitarget fecal immunochemical and stool DNA (FIT-sDNA) test for CRC screening. Each participant was asked to provide a stool sample prior to bowel preparation, and FIT-sDNA test and FIT were performed independently of colonoscopy. We found that 186 (4.4%) were confirmed to have CRC, and 375 (8.8%) had advanced precancerous neoplasia among the high CRC risk individuals. The sensitivity of detecting CRC for FIT-sDNA test was 91.9% (95% CI, 86.8-95.3), compared with 62.4% (95% CI, 54.9-69.3) for FIT (P < 0.001). The sensitivity for detecting advanced precancerous neoplasia was 63.5% (95% CI, 58.3-68.3) for FIT-sDNA test, compared with 30.9% (95% CI, 26.3-35.6) for FIT (P < 0.001). Multitarget FIT-sDNA test detected more colorectal advanced neoplasia than FIT. Overall, these findings indicated that in areas with limited colonoscopy resources, FIT-sDNA test could be a promising further risk triaging modality to select patients for colonoscopy in CRC screening.

Keywords: FIT‐sDNA test; colorectal cancer; high‐risk population; risk triaging modality.

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Conflict of interest statement

Xiao‐Tian Yu is the Medical Director, Ning Lv is the Chief Technology Officer, and Yi‐You Chen is the Chief Scientist at Hangzhou New Horizon Health Technology Company. The other authors declare no conflicts of interest.

Figures
FIGURE 1

Study flow chart. Among the…

FIGURE 1

Study flow chart. Among the 4,245 evaluable participants, 186 participants were diagnosed with…

FIGURE 1

Study flow chart. Among the 4,245 evaluable participants, 186 participants were diagnosed with CRC (4.4% prevalence), and 375 participants were found to have advanced precancerous neoplasia (8.8% prevalence). Despite the fact that 55.7% of the overall participants were females, 104 (55.9%) participants who had CRC and 241 (64.3%) participants who had advanced precancerous neoplasia were males (Table 1). Among the participants with confirmed CRC, 85 participants had early‐stage CRC (Stages I to II), and 140 participants had CRC Stage I to III. CRC was found more frequently in the distal section of the colon than the proximal section (154 vs. 32). Details of the clinical findings are shown in Table S1 (in the Appendix, Supporting information). CRC, colorectal cancer.

FIGURE 2

Sensitivity of the multitarget FIT‐sDNA…

FIGURE 2

Sensitivity of the multitarget FIT‐sDNA test and the commercial FIT according to the…

FIGURE 2

Sensitivity of the multitarget FIT‐sDNA test and the commercial FIT according to the CRC and advanced precancerous neoplasia subgroups. (A) Sensitivities of the FIT‐DNA test and FIT for the detection of CRC according to the tumor stage. (B) CRC and advanced precancerous neoplasia were detected according to the location in the colon. (C) Sensitivities of the FIT‐DNA test and FIT for the detection of advanced adenoma with HGIN, LGIN, TSA, and SSA/P ≥1 cm. (D) Sensitivities of the FIT‐DNA test and FIT according to neoplasia size. CRC, colorectal cancer; FIT, fecal immunochemical test; SSA, sessile serrated adenoma; TSA, traditional serrated adenoma.