Evidence map›Paper›PMID 24901436›Full record

ArticlePloS one2014

Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study.

David A Johnson, Robert L Barclay, Klaus Mergener, Gunter Weiss, Thomas König, Jürgen Beck, Nicholas T Potter

7 registry-linked trialsOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 92 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 14 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT01580540 completednot on this map

Comparison of the Performance of the Epi proColon and Fecal ImmunochemicalTest Post Colonoscopy in Subjects With Colorectal Cancer and Pre Colonoscopy in Subjects From a Guideline-Eligible Screening Population

TypeobservationalSponsorEpigenomics, IncRan2012 to 2012Enrolled336ConditionsColorectal Cancer
NCT03218423 unknown statusnot on this mapstarted 2017, after this paper: background citation

Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)

TypeobservationalSponsorEpigenomics, IncRan2017 to 2024Enrolled4,500ConditionsColorectal Cancer, Colorectal NeoplasmsArmsEpi proColon
NCT05224596 unknown statusnot on this mapstarted 2021, after this paper: background citation

Gastric Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

TypeobservationalSponsorShanghai Zhongshan HospitalRan2021 to 2022Enrolled498ConditionsCancerArmsBlood draw and blood-based biomarkers analyses
NCT05227261 completednot on this mapstarted 2022, after this paper: background citation

Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA

TypeobservationalSponsorGene SolutionsRan2022 to 2024Enrolled9,057ConditionsCancer, Lung, Cancer, Breast, Cancer Liver, Cancer, Colorectal
NCT05495685 unknown statusnot on this mapstarted 2022, after this paper: background citation

Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

TypeobservationalSponsorChanghai HospitalRan2022 to 2024Enrolled450ConditionsCancer
NCT05556603 recruitingnot on this mapstarted 2022, after this paper: background citation

Pancreatic Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

TypeobservationalSponsorRuijin HospitalRan2022 to 2029Enrolled7,062ConditionsCancer
NCT07126626 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Multi-center Prospective Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer

TypeobservationalSponsorGene SolutionsRan2025 to 2027Enrolled1,184ConditionsLung Diseases, Lung Cancer Screening
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 14 syntheses or guidelines pooled it, 177 citations in OpenAlex.

  1. Pooled it
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  10. Diagnostic Value and Clinical Significance of Methylated SEPT9 for Colorectal Cancer: A Meta-Analysis.Medical science monitor : international medical journal of experimental and clinical research · 2019
    Pooled it
  11. Diagnostic Performance of IntestinalChinese medical journal · 2018
    Pooled it
  12. Pooled it
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  14. Pooled it
  15. Epi proColonMolecular diagnosis & therapy · 2020
    Trial
  16. Validation of the SHOX2/PTGER4 DNA Methylation Marker Panel for Plasma-Based Discrimination between Patients with Malignant and Nonmalignant Lung Disease.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2017
    Trial
  17. Review
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  19. Article
  20. Article

32 more citing papers are in PubMed but not listed here.

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

7 authors at 5 institutions in 2 countries.

David A JohnsonGastroenterology Division, Eastern VA Medical School, Norfolk, Virginia, United States of America.
Robert L BarclayRockford Gastroenterology Associates, Ltd., Rockford, Illinois, United States of America.
Klaus MergenerDigestive Health Specialists, Tacoma, Washington, United States of America.
Gunter WeissEpigenomics AG, Berlin Germany.
Thomas KönigEpigenomics AG, Berlin Germany.
Jürgen BeckEpigenomics AG, Berlin Germany.
Nicholas T PotterMolecular Pathology Laboratory Network, Inc., Maryville, Tennessee, United States of America.
Epigenomics (Germany) · DEEastern Virginia Medical School · USFlorida Digestive Health Specialists · USMolecular Pathology Laboratory Network (United States) · USRockford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundScreening improves outcomes related to colorectal cancer (CRC); however, suboptimal participation for available screening tests limits the full benefits of screening. Non-invasive screening using a blood based assay may potentially help reach the unscreened population.

objectiveTo compare the performance of a new Septin9 DNA methylation based blood test with a fecal immunochemical test (FIT) for CRC screening.

designIn this trial, fecal and blood samples were obtained from enrolled patients. To compare test sensitivity for CRC, patients with screening identified colorectal cancer (n = 102) were enrolled and provided samples prior to surgery. To compare test specificity patients were enrolled prospectively (n = 199) and provided samples prior to bowel preparation for screening colonoscopy. MEASUREMENTS: Plasma and fecal samples were analyzed using the Epi proColon and OC Fit-Check tests respectively.

resultsFor all samples, sensitivity for CRC detection was 73.3% (95% CI 63.9-80.9%) and 68.0% (95% CI 58.2-76.5%) for Septin9 and FIT, respectively. Specificity of the Epi proColon test was 81.5% (95% CI 75.5-86.3%) compared with 97.4% (95% CI 94.1-98.9%) for FIT. For paired samples, the sensitivity of the Epi proColon test (72.2% -95% CI 62.5-80.1%) was shown to be statistically non-inferior to FIT (68.0%-95% CI 58.2-76.5%). When test results for Epi proColon and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%.

conclusionsAt a sensitivity of 72%, the Epi proColon test is non- inferior to FIT for CRC detection, although at a lower specificity. With negative predictive values of 99.8%, both methods are identical in confirming the absence of CRC.

trial registrationClinicalTrials.gov NCT01580540.

Indexed as

Early Detection of CancerOccult BloodAgedAged, 80 and overColonoscopyColorectal NeoplasmsFemaleHumansMaleMass ScreeningMiddle AgedNeoplasm StagingProspective StudiesReproducibility of ResultsSensitivity and SpecificitySeptinsSEPTIN9 protein, humanSeptins

Identifiers

PMID24901436
PMCPMC4046970
OpenAlexW2118828352

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

and 1 more above

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.