Evidence map›Paper›PMID 34590051›Full record

ArticleJTO clinical and research reports2021

A Pan-Canadian Validation Study for the Detection of

Shamini Selvarajah, Sophie Plante, Marsha Speevak, Andrea Vaags, Darren Hamelinck, Martin Butcher, Elizabeth McCready, Daria Grafodatskaya, Normand Blais, Danh Tran-Thanh and 14 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JTO clinical and research reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

24 authors.

Shamini SelvarajahDepartment of Laboratory Medicine and Genetics, Trillium Health Partners, Mississauga, Ontario, Canada.
Sophie PlanteInstitut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Quebec, Canada.
Marsha SpeevakDepartment of Laboratory Medicine and Genetics, Trillium Health Partners, Mississauga, Ontario, Canada.
Andrea VaagsDepartment of Laboratory Medicine and Genetics, Trillium Health Partners, Mississauga, Ontario, Canada.
Darren HamelinckDepartment of Laboratory Medicine and Genetics, Trillium Health Partners, Mississauga, Ontario, Canada.
Martin ButcherDepartment of Oncology, McMaster University, Hamilton, Ontario, Canada.
Elizabeth McCreadyDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.
Daria GrafodatskayaDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.
Normand BlaisCentre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Danh Tran-ThanhCentre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Xiaoduan WengCentre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Rami NassabeinCentre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Wenda GreerQueen Elizabeth II Health Sciences Center, Department of Pathology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Ryan N WaltonAstraZeneca Canada, Mississauga, Ontario, Canada.
Bryan LoDepartment of Pathology and Laboratory Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
Doug DemetrickDepartment of Pathology and Laboratory Medicine, University of Calgary, Calgary, Alberta, Canada.
Stephanie SantosMolecular Genetics Laboratory, Molecular Diagnostics Division, London Health Sciences Centre, London, Ontario, Canada.
Bekim SadikovicMolecular Genetics Laboratory, Molecular Diagnostics Division, London Health Sciences Centre, London, Ontario, Canada.
Xiao ZhangLaboratory Genetics, Kingston Health Sciences Center, Kingston, Ontario, Canada.
Tong ZhangDepartment of Clinical Laboratory Genetics, University Health Network, Toronto, Ontario, Canada.
Tara SpenceDepartment of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada.
Tracy StockleyDepartment of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
Harriet FeilotterLaboratory Genetics, Kingston Health Sciences Center, Kingston, Ontario, Canada.
Philippe JoubertInstitut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec, Quebec, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGenotyping circulating tumor DNA (ctDNA) is a promising noninvasive clinical tool to identify the

methodsIn phase 1, commercial reference standards were distributed to participating clinical laboratories, to use their existing platforms for mutation detection. Baseline performance characteristics were established using known and blinded engineered plasma samples spiked with predetermined concentrations of T790M, L858R, and exon 19 deletion variants. In phase II, peripheral blood collected from local patients with known

resultsAll laboratories in phase 1 detected the variants at 0.5 % and 5.0 % allele frequencies, with no false positives. In phase 2, the concordance with the reference laboratory for detection of both the primary and resistance mutation was high, with next-generation sequencing and droplet digital polymerase chain reaction exhibiting the best overall concordance. Data also suggested that the ability to detect mutations at clinically relevant limits of detection is generally not platform-specific, but rather impacted by laboratory-specific practices.

conclusionsDiscrepancies among sending laboratories using the same assay suggest that laboratory-specific practices may impact performance. In addition, a negative or inconclusive ctDNA test should be followed by tumor testing when possible.

Indexed as

EGFR T790M variantLiquid biopsyNon–small cell lung cancerPlasma ctDNA testing

Identifiers

PMID34590051
PMCPMC8474449

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.