Evidence map›Paper›PMID 39379942›Full record

Trial reportBMC medicine2024

Evaluation of a plasma cell-free DNA methylation test for colorectal cancer diagnosis: a multicenter clinical study.

Zhijie Wang, Zixuan He, Rong Lin, Zhijie Feng, Xiuling Li, Xiangyu Sui, Lun Gu, Tian Xia, Dihan Zhou, Bali Zhao and 3 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05508503 (Validation of a ctDNA Methylation-based Dual-target Test for the Detection of Colorectal Cancer), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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.

NCT05508503 completednot on this map

Validation of a ctDNA Methylation-based Dual-target Test for the Detection of Colorectal Cancer: a Multicenter Clinical Study

TypeobservationalSponsorChanghai HospitalRan2022 to 2023Enrolled1,378ConditionsColorectal Cancer, Colorectal AdenomaArmsTest of methylated NTMT1 and MAP3K14-AS1, FIT
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Observational
  11. 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

13 authors.

Zhijie Wang *Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
Zixuan He *Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
Rong Lin *Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Zhijie Feng *Department of Gastroenterology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.
Xiuling Li *Department of Gastroenterology, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, China.
Xiangyu Sui *Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
Lun GuDepartment of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
Tian XiaDepartment of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
Dihan ZhouWuhan Ammunition Life-Tech Co, Ltd, Wuhan, China.
Bali ZhaoWuhan Ammunition Life-Tech Co, Ltd, Wuhan, China.
Yanqing LiDepartment of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China. liyanqing@sdu.edu.cn.
Zhaoshen LiDepartment of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China. lizhaoshen0708@sina.com.
Yu BaiDepartment of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China. baiyu1998@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA blood-based diagnostic test is a promising strategy for colorectal cancer (CRC). The MethyDT test (IColohunter), which detects methylation levels of NTMT1 and MAP3K14-AS1, exhibited potential in discriminating CRC, but its clinical performance needs to be validated in large-scale populations.

methodsA multicenter, double-blinded, cross-sectional study that enrolled 1194 participants was performed. Plasma samples were collected to detect methylation levels of NTMT1 and MAP3K14-AS1 using quantitative methylation-specific PCR with the MethyDT test, and the accuracy was further evaluated by Sanger sequencing.

resultsThe sensitivities of the MethyDT test for detecting CRC, early stages of CRC (I and II), advanced adenoma (AA), and high-grade intraepithelial neoplasia (HGIN) were 91.2% (95% confidence interval [CI], 88.4-94.0), 87.4% (95% CI, 82.5-92.2), 43.5% (95% CI, 35.7-51.4), and 72.7% (95% CI, 57.5-87.9), respectively. The specificities for participants with non-AA, interfering diseases (ID), and no evidence of disease (NED) were 85.0% (95% CI, 78.8-91.3), 93.7% (95% CI, 91.4-95.9) and 97.3% (95% CI, 90.5-99.7), respectively, and its overall specificity for all-controls was 92.4% (95% CI, 90.3-94.4). The consistency of the MethyDT test with pathology for CRC was high with a kappa value of 0.830 (95% CI, 0.795-0.865). Additionally, the MethyDT test was comparable to Sanger sequencing for detecting methylation with kappa values > 0.97.

conclusionsThe MethyDT test demonstrates excellent sensitivity and specificity for CRC and high consistency with Sanger sequencing for methylation, suggesting it may serve as a potential noninvasive diagnostic tool for the detection of CRC.

trial registrationThis clinical trial has been registered in ClinicalTrials.gov (NCT05508503).

Indexed as

Colorectal NeoplasmsDNA MethylationAdultAgedBiomarkers, TumorCell-Free Nucleic AcidsCross-Sectional StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedSensitivity and SpecificityBiomarkers, TumorCell-Free Nucleic AcidsCell-free DNAColorectal cancerLiquid biopsyMethylation

Identifiers

PMID39379942
PMCPMC11462859

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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.