Evidence map›Paper›PMID 33858326›Full record

Trial reportBMC gastroenterology2021

Colorectal cancer screening using a stool DNA-based SDC2 methylation test: a multicenter, prospective trial.

Chang Woo Kim, Hyunjin Kim, Hyoung Rae Kim, Bong-Hyeon Kye, Hyung Jin Kim, Byung Soh Min, Tae Jeong Oh, Sungwhan An, Suk-Hwan Lee

Registry-linked trialOpen access · goldAbstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in BMC gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04304131 (Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test), 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
1.9field-weighted citation impact, top 11% 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.

NCT04304131 nacompletednot on this map

Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

TypeinterventionalSponsorKyung Hee University Hospital at GangdongRan2020 to 2022Enrolled1,210ConditionsColorectal Cancer, Colon Polyp, HealthyArmsEarlytect Colon Cancer
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Fecal methylated syndecan-2 (Cancer pathogenesis and therapy · 2025
    Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Methylation ofFrontiers in molecular biosciences · 2021
    Article
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

9 authors at 4 institutions in 1 country.

Chang Woo KimDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Seoul, Gangdong-gu, 05278, Korea.
Hyunjin KimDepartment of Surgery, Koo Hospital, 141 Gamsambuk-gil, Daegu, Korea.
Hyoung Rae KimDepartment of Surgery, Busan Hangun Hospital, 348 Chungnyeol-daero, Dongnae-gu, Busan, Korea.
Bong-Hyeon KyeDepartment of Surgery, St. Vincent's Hospital, The Catholic University of Korea, 93 Jungbu-daero, Suwon, Korea.
Hyung Jin KimDepartment of Surgery, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Tongil-ro, Seoul, 1021, Korea.
Byung Soh MinDepartment of Surgery, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seoul, Korea.
Tae Jeong OhGenomictree, Inc, 44-6 Techno 10-ro Yuseong-gu, Daejeon, Korea.
Sungwhan AnGenomictree, Inc, 44-6 Techno 10-ro Yuseong-gu, Daejeon, Korea.
Suk-Hwan LeeDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892 Dongnam-ro, Seoul, Gangdong-gu, 05278, Korea. leeshdr@gmail.com.
Catholic University of Korea · KRKyung Hee University Hospital at Gangdong · KRThe Catholic University of Korea St. Vincent's Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevention and early detection of colorectal cancer (CRC) is a global priority, with many countries conducting population-based CRC screening programs. Although colonoscopy is the most accurate diagnostic method for early CRC detection, adherence remains low because of its invasiveness and the need for extensive bowel preparation. Non-invasive fecal occult blood tests or fecal immunochemical tests are available; however, their sensitivity is relatively low. Syndecan-2 (SDC2) is a stool-based DNA methylation marker used for early detection of CRC. Using the EarlyTect™-Colon Cancer test, the sensitivity and specificity of SDC2 methylation in stool DNA for detecting CRC were previously demonstrated to be greater than 90%. Therefore, a larger trial to validate its use for CRC screening in asymptomatic populations is now required.

methodsAll participants will collect their stool (at least 20 g) before undergoing screening colonoscopy. The samples will be sent to a central laboratory for analysis. Stool DNA will be isolated using a GT Stool DNA Extraction kit, according to the manufacturer's protocol. Before performing the methylation test, stool DNA (2 µg per reaction) will be treated with bisulfite, according to manufacturer's instructions. SDC2 and COL2A1 control reactions will be performed in a single tube. The SDC2 methylation test will be performed using an AB 7500 Fast Real-time PCR system. C DISCUSSION: This trial investigates the clinical performance of a device that allows quantitative detection of a single DNA marker, SDC2 methylation, in human stool DNA in asymptomatic populations. The results of this trial are expected to be beneficial for CRC screening and may help make colonoscopy a selective procedure used only in populations with a high risk of CRC.

trial registrationThis trial (NCT04304131) was registered at ClinicalTrials.gov on March 11, 2020 and is available at https://clinicaltrials.gov/ct2/show/NCT04304131?cond=NCT04304131&draw=2&rank=1 .

Indexed as

Colorectal NeoplasmsOccult BloodColonoscopyEarly Detection of CancerFecesHumansProspective StudiesSensitivity and SpecificitySyndecan-2SDC2 protein, humanSyndecan-2BiomarkerColorectal cancerDNA methylationEarly detectionSyndecan-2

Identifiers

PMID33858326
PMCPMC8050895
OpenAlexW3155916313

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.