Evidence map›Paper›PMID 36203138›Full record

ArticleBMC gastroenterology2022

A simplified multiplex methylated DNA testing for early detection of colorectal cancer in stool DNA.

Yanmiao Dai, Guodong Zhao, Jun Yang, Xilang Zhou, Shangmin Xiong, Xirong Lu, Liming Gao, Jianfang Wu, Zouhua Xu, Sujuan Fei and 2 more

Open access · goldAbstract read
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 36% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Review
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

12 authors at 5 institutions in 1 country.

Yanmiao Dai *Department of Spleen and Stomach Diseases, Kunshan Hospital of Traditional Chinese Medicine, Kunshan, 215300, Jiangsu, China.
Guodong Zhao *Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, 215300, Jiangsu, China.
Jun Yang *Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, Jiangsu, China.
Xilang ZhouDepartment of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, Jiangsu, China.
Shangmin XiongZhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, 215300, Jiangsu, China.
Xirong LuDepartment of Spleen and Stomach Diseases, Kunshan Hospital of Traditional Chinese Medicine, Kunshan, 215300, Jiangsu, China.
Liming GaoDepartment of Spleen and Stomach Diseases, Kunshan Hospital of Traditional Chinese Medicine, Kunshan, 215300, Jiangsu, China.
Jianfang WuDepartment of Spleen and Stomach Diseases, Kunshan Hospital of Traditional Chinese Medicine, Kunshan, 215300, Jiangsu, China.
Zouhua XuDepartment of Spleen and Stomach Diseases, Kunshan Hospital of Traditional Chinese Medicine, Kunshan, 215300, Jiangsu, China.
Sujuan FeiDepartment of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221002, Jiangsu, China. xyfyfeisj99@163.com.
Minxue ZhengZhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, 215300, Jiangsu, China. minxue.zheng@sibet.ac.cn.
Hongwei XuDepartment of Spleen and Stomach Diseases, Kunshan Hospital of Traditional Chinese Medicine, Kunshan, 215300, Jiangsu, China. niannian5727@126.com.
Shanghai University of Traditional Chinese Medicine · CNXuzhou Medical College · CNDuke Kunshan University · CNTraditional Chinese Medicine Hospital of Kunshan · CNZhejiang University · CN

Funding

Key Technologies R & D Program for Social Development of Jiangsu Province BE2019688Key Technologies R & D Program for Social Development of Xuzhou KC17184Special Project of Diagnosis and Treatment Technology for Clinical Key Diseases in Suzhou LCZX201927
6 · The paper itself

Abstract

backgroundColoDefense1.0 assay has demonstrated its excellent sensitivity and specificity for early detection of colorectal cancer (CRC) by detecting the methylation levels of SDC2 and SEPT9, while exhibited limitations on relatively large sample capacity required and limited detection throughput by applying triplicate PCR reactions for each sample. In this study, ColoDefense1.0 was simplified and optimized into ColoDefense2.0 in a single PCR reaction.

methodsA total 529 stool specimens were collected, and 244 CRC patients, 34 patients with advanced adenomas (AA), 64 with small polyps (SP) and 187 control subjects were divided in training and validation cohorts. Methylation levels of SEPT9 and SDC2 were examined by qPCR reactions in triplicate or single.

resultsThe stool DNA quantity stored in preservative buffer at 37 °C up to 7 days exhibited no significant decrease. In the training cohort, when the number of replicates reduced from 3 to 1, the overall performance of ColoDefense2.0 was identical to that of ColoDefense1.0, showing sensitivities of 71.4% for AA and 90.8% for all stage CRC with a specificity of 92.9%. In the validation cohort, sensitivities of SP, AA and CRC using ColoDefense2.0 were 25.0%, 55.0% and 88.2%, increased from 14.1% (20.3%), 40.0% (40.0%) and 79.4% (67.6%) using SDC2 (SEPT9) alone; along with an overall specificity of 90.2%, decreased from 94.1% (95.1%) using SDC2 (SEPT9) alone.

conclusionThe simplified ColoDefense test maintained the overall performance while reduced the number of PCR reactions to 1/3, and provided an effective and convenient tool to detect early CRC and precancerous lesions and potentially improve the compliance of screening.

Indexed as

Colorectal NeoplasmsSyndecan-2Biomarkers, TumorDNADNA MethylationEarly Detection of CancerHumansSensitivity and SpecificityBiomarkers, TumorDNASyndecan-2Colorectal cancerDNA methylationEarly detectionSimplifiedStool

Identifiers

PMID36203138
PMCPMC9540293
OpenAlexW4302424607

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.