Evidence map›Paper›PMID 30092778›Full record

ArticleBMC cancer2018

International pilot external quality assessment scheme for analysis and reporting of circulating tumour DNA.

Cleo Keppens, Elisabeth M C Dequeker, Simon J Patton, Nicola Normanno, Francesca Fenizia, Rachel Butler, Melanie Cheetham, Jennifer A Fairley, Hannah Williams, Jacqueline A Hall and 3 more

Abstract read
In one paragraph

Article in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing 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.

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

28 citing papers in PubMed.

  1. Review
  2. Review
  3. Advances in laboratory medicine · 2025
    Article
  4. Article
  5. Article
  6. Liquid biopsy to personalize treatment for metastatic prostate cancer.American journal of translational research · 2024
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. A Review of Circulating Tumor DNA in the Diagnosis and Monitoring of Esophageal Cancer.Medical science monitor : international medical journal of experimental and clinical research · 2022
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
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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

13 authors.

Cleo KeppensDepartment of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35d, 3000, Leuven, Belgium. cleo.keppens@kuleuven.be.ORCID http://orcid.org/0000-0002-4498-8386
Elisabeth M C DequekerDepartment of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35d, 3000, Leuven, Belgium.
Simon J PattonEuropean Molecular Quality Network (EMQN), Manchester Centre for Genomic Medicine, St Mary's Hospital, Manchester, M13 9WL, UK.
Nicola NormannoCell Biology and Biotherapy Unit, Instituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Napoli, Italy.
Francesca FeniziaCell Biology and Biotherapy Unit, Instituto Nazionale Tumori "Fondazione Giovanni Pascale", IRCCS, Napoli, Italy.
Rachel ButlerAll Wales Genetic Laboratory, Institute of Medical Genetics, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, UK.
Melanie CheethamEuropean Molecular Quality Network (EMQN), Manchester Centre for Genomic Medicine, St Mary's Hospital, Manchester, M13 9WL, UK.
Jennifer A FairleyUK NEQAS for Molecular Genetics, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
Hannah WilliamsUK NEQAS for Molecular Genetics, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
Jacqueline A HallInternational Quality Network for Pathology (IQN Path) Association Sans But Lucratif (A.S.B.L), 3A Sentier de l'Espérance, L-1474, Luxembourg City, Luxembourg.
Ed SchuuringEuropean Society of Pathology (ESP), Anderlecht, Belgium.
Zandra C DeansUK NEQAS for Molecular Genetics, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.
IQN Path ASBL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMolecular analysis of circulating tumour DNA (ctDNA) is becoming increasingly important in clinical treatment decisions. A pilot External Quality Assessment (EQA) scheme for ctDNA analysis was organized by four European EQA providers under the umbrella organization IQN Path, in order to investigate the feasibility of delivering an EQA to assess the detection of clinically relevant variants in plasma circulating cell-free DNA (cfDNA) and to analyze reporting formats.

methodsThirty-two experienced laboratories received 5 samples for EGFR mutation analysis and/or 5 samples for KRAS and NRAS mutation analysis. Samples were artificially manufactured to contain 3 mL of human plasma with 20 ng/mL of fragmented ctDNA and variants at allelic frequencies of 1 and 5%.

resultsThe scheme error rate was 20.1%. Higher error rates were observed for RAS testing when compared to EGFR analysis, for allelic frequencies of 1% compared to 5%, and for cases including 2 different variants. The reports over-interpreted wild-type results and frequently failed to comment on the amount of cfDNA extracted.

conclusionsThe pilot scheme demonstrated the feasibility of delivering a ctDNA EQA scheme and the need for such a scheme due to high error rates in detecting low frequency clinically relevant variants. Recommendations to improve reporting of cfDNA are provided.

Indexed as

Quality Assurance, Health CareCell-Free Nucleic AcidsCirculating Tumor DNAErbB ReceptorsHumansMutationNeoplasmsProto-Oncogene Proteins p21(ras)Cell-Free Nucleic AcidsCirculating Tumor DNAEGFR protein, humanErbB ReceptorsKRAS protein, humanProto-Oncogene Proteins p21(ras)cfDNAColorectal cancerctDNAEGFRKRASLung cancerMutation testingNRAS

Identifiers

PMID30092778
PMCPMC6085634

What OpenQuestion holds

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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.