Evidence map›Paper›PMID 33126908›Full record

Trial reportClinical epigenetics2020

Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study.

Jianping Wang, Side Liu, Hui Wang, Lei Zheng, Changchun Zhou, Guoxin Li, Rongkang Huang, Huaiming Wang, Chujun Li, Xinjuan Fan and 17 more

2 registry-linked trialsOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical epigenetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04786704 completednot on this mapstarted 2021, after this paper: background citation

Detection of Advanced Colorectal Neoplasia for Stool DNA in Asymptomatic Chinese Population : A Multi-central Community-based Screening Study

TypeobservationalSponsorChanghai HospitalRan2021 to 2022Enrolled12,106ConditionsColorectal Cancer, Colorectal Neoplasm, Advanced Adenoma, AdenomaArmsStool-based SDC2 DNA methylation test, quantitative Fecal immunochemical test
NCT05530746 unknown statusnot on this mapstarted 2022, after this paper: background citation

Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of Colorectal Cancer

TypeobservationalSponsorChanghai HospitalRan2022 to 2023Enrolled500ConditionsColorectal Cancer, Precancerous Lesion, Inflammatory Bowel Diseases
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.

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  15. Fecal methylated syndecan-2 (Cancer pathogenesis and therapy · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 4 institutions in 1 country.

Jianping WangDepartment of Colorectal Surgery, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, , Sun Yat-Sen University, Yuancun Erheng Road, Guangzhou, 510655, Guangdong, China. wangjpgz@126.com.
Side LiuDepartment of Gastroenterology, Nanfang Hospital, Southern Medical University, 1838 Guangzhou Avenue North, Guangzhou, Guangdong, China. liuside@163.com.
Hui WangDepartment of Colorectal Surgery, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, , Sun Yat-Sen University, Yuancun Erheng Road, Guangzhou, 510655, Guangdong, China.
Lei ZhengClinical Laboratory, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Changchun ZhouClinical Laboratory, Shandong Provincial Key Laboratory of Cancer Radiation, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, 440 Jiyan Road, Jinan, Shandong, China.
Guoxin LiDepartment of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Rongkang HuangDepartment of Colorectal Surgery, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, , Sun Yat-Sen University, Yuancun Erheng Road, Guangzhou, 510655, Guangdong, China.
Huaiming WangDepartment of Colorectal Surgery, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, , Sun Yat-Sen University, Yuancun Erheng Road, Guangzhou, 510655, Guangdong, China.
Chujun LiDepartment of Gastrointestinal Endoscopy, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Xinjuan FanDepartment of Pathology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Xinhui FuLaboratory of Molecular Diagnostics, Department of Pathology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Xinying WangDepartment of Gastroenterology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Hongliang GuoDepartment of Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Jie GuanDepartment of Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Yanlai SunDepartment of Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Xilin SongDepartment of Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Zengjun LiDepartment of Endoscopy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Dianbin MuDepartment of Pathology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Jujie SunDepartment of Pathology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, Jinan, Shandong, China.
Xianglin LiuCreative Biosciences (Guangzhou) CO., Ltd., Guangzhou, Guangdong, China.
Yan QiCreative Biosciences (Guangzhou) CO., Ltd., Guangzhou, Guangdong, China.
Feng NiuCreative Biosciences (Guangzhou) CO., Ltd., Guangzhou, Guangdong, China.
Chunhua ChenCreative Biosciences (Guangzhou) CO., Ltd., Guangzhou, Guangdong, China.
Xiaolin WuCreative Biosciences (Guangzhou) CO., Ltd., Guangzhou, Guangdong, China.
Xianshu WangCreative Biosciences (Guangzhou) CO., Ltd., Guangzhou, Guangdong, China.
Xianrang SongClinical Laboratory, Shandong Provincial Key Laboratory of Cancer Radiation, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, 440 Jiyan Road, Jinan, Shandong, China. sxr@vip.163.com.
Hongzhi ZouDepartment of Colorectal Surgery, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, , Sun Yat-Sen University, Yuancun Erheng Road, Guangzhou, 510655, Guangdong, China. zouhongzhi@creativebio.cn.ORCID 0000-0002-4870-6913
Shandong Tumor Hospital · CNSun Yat-sen University · CNBioscience (China) · CNNanfang Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsStool DNA testing is an emerging and attractive option for colorectal cancer (CRC) screening. We previously evaluated the feasibility of a stool DNA (sDNA) test of methylated SDC2 for CRC detection. The aim of this study was to assess its performance in a multicenter clinical trial setting.

methodsEach participant was required to undergo a sDNA test and a reference colonoscopy. The sDNA test consists of quantitative assessment of methylation status of SDC2 promoter. Results of real-time quantitative methylation-specific PCR were dichotomized as positive and negative, and the main evaluation indexes were sensitivity, specificity, and kappa value. All sDNA tests were performed and analyzed independently of colonoscopy.

resultsAmong the 1110 participants from three clinical sites analyzed, 359 and 38 were diagnosed, respectively, with CRC and advanced adenomas by colonoscopy. The sensitivity of the sDNA test was 301/359 (83.8%) for CRC, 16/38 (42.1%) for advanced adenomas, and 134/154 (87.0%) for early stage CRC (stage I-II). Detection rate did not vary significantly according to age, tumor location, differentiation, and TNM stage, except for gender. The follow-up testing of 40 postoperative patients with CRC returned negative results as their tumors had been surgically removed. The specificity of the sDNA test was 699/713 (98.0%), and unrelated cancers and diseases did not seem to interfere with the testing. The kappa value was 0.84, implying an excellent diagnostic consistency between the sDNA test and colonoscopy.

conclusionNoninvasive sDNA test using methylated SDC2 as the exclusive biomarker is a clinically viable and accurate CRC detection method. CHINESE CLINICAL TRIAL REGISTRY: Chi-CTR-TRC-1900026409, retrospectively registered on October 8, 2019; http://www.chictr.org.cn/edit.aspx?pid=43888&htm=4 .

Indexed as

AdenomaAdultAgedBiomarkers, TumorCase-Control StudiesColonic NeoplasmsColonoscopyColorectal NeoplasmsDNADNA MethylationEarly Detection of CancerEvaluation Studies as TopicFeasibility StudiesFecesFemaleHumansBiomarkers, TumorDNASDC2 protein, humanSyndecan-2Advanced adenomaColorectal cancerMethylationStool DNA test

Identifiers

PMID33126908
PMCPMC7602331
OpenAlexW3095421680

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.