Evidence map›Paper›PMID 31055023›Full record

ArticleThe Journal of molecular diagnostics : JMD2019

Multilaboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements.

Hua-Jun He, Erica V Stein, Yves Konigshofer, Thomas Forbes, Farol L Tomson, Russell Garlick, Emiko Yamada, Tony Godfrey, Toshiya Abe, Koji Tamura and 16 more

Abstract read
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

11 citing papers in PubMed.

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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

26 authors.

Hua-Jun HeMaterial Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, Maryland.
Erica V SteinMaterial Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, Maryland.
Yves KonigshoferSeraCare Life Sciences, Inc., Milford, Massachusetts.
Thomas ForbesFrederick National Laboratory for Cancer Research, National Cancer Institute, Leidos Biomedical Research, Inc., Frederick, Maryland.
Farol L TomsonSeraCare Life Sciences, Inc., Milford, Massachusetts.
Russell GarlickSeraCare Life Sciences, Inc., Milford, Massachusetts.
Emiko YamadaBoston University School of Medicine, Boston, Massachusetts.
Tony GodfreyBoston University School of Medicine, Boston, Massachusetts.
Toshiya AbeJohns Hopkins University School of Medicine, Baltimore, Maryland.
Koji TamuraJohns Hopkins University School of Medicine, Baltimore, Maryland.
Michael BorgesJohns Hopkins University School of Medicine, Baltimore, Maryland.
Michael GogginsJohns Hopkins University School of Medicine, Baltimore, Maryland.
Sandra ElmoreUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina.
Margaret L GulleyUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina.
Jessica L LarsonAsuragen, Inc., Austin, Texas.
Lando RingelAsuragen, Inc., Austin, Texas.
Brian C HaynesAsuragen, Inc., Austin, Texas.
Chris KarlovichFrederick National Laboratory for Cancer Research, National Cancer Institute, Leidos Biomedical Research, Inc., Frederick, Maryland.
P Mickey WilliamsFrederick National Laboratory for Cancer Research, National Cancer Institute, Leidos Biomedical Research, Inc., Frederick, Maryland.
Aaron GarnettArcher Diagnostics, Inc., Boulder, Colorado.
Anders StåhlbergDepartment of Pathology and Genetics, Sahlgrenska Cancer Center, Institute of Biomedicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden; Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Sweden.
Stefan FilgesDepartment of Pathology and Genetics, Sahlgrenska Cancer Center, Institute of Biomedicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
Lynn SorbaraEarly Detection Research Network, National Cancer Institute, Bethesda, Maryland.
Mathew R YoungEarly Detection Research Network, National Cancer Institute, Bethesda, Maryland.
Sudhir SrivastavaEarly Detection Research Network, National Cancer Institute, Bethesda, Maryland.
Kenneth D ColeMaterial Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, Maryland. Electronic address: kenneth.cole@nist.gov.

Funding

Using markers to improve pancreatic cancer screening and surveillance: a multi-center studyU01CA210170 · NCI · JOHNS HOPKINS UNIVERSITY · PI Michael G. Goggins · 2016 to 2026
$9.3M
Network Group Integrated Translational Science Centers ApplicationU10CA181009 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HAYES, DAVID N, PEROU, CHARLES M · 2014 to 2018
$3.4M
Development of diagnostic and prognostic tests for esophageal adenocarcinomaR01CA208599 · NCI · BOSTON UNIVERSITY MEDICAL CAMPUS · PI GODFREY, TONY E · 2017 to 2022
$2.4M
EndoGenus Toolkit: A Biometric Method for Absolute Quantification of Tumor Markers by Massive Parallel SequencingR21CA229037 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GULLEY, MARGARET L · 2018 to 2022
$613k
Improving rare variant detection in next generation sequencing of liquid biopsies with a molecular barcoding technique that combines a novel primer structure and sophisticated bioinformatics methodsR43GM128522 · NIGMS · ASURAGEN, INC. · PI LARSON, JESSICA LYNN · 2018 to 2018
$225k
NCI NIH HHS R01 CA208599NCI NIH HHS R21 CA229037NCI NIH HHS U01 CA210170NCI NIH HHS U10 CA181009NIGMS NIH HHS R43 GM128522
6 · The paper itself

Abstract

We conducted a multilaboratory assessment to determine the suitability of a new commercially available reference material with 40 cancer variants in a background of wild-type DNA at four different variant allele frequencies (VAFs): 2%, 0.50%, 0.125%, and 0%. The variants include single nucleotides, insertions, deletions, and two structural variations selected for their clinical importance and to challenge the performance of next-generation sequencing (NGS) methods. Fragmented DNA was formulated to simulate the size distribution of circulating wild-type and tumor DNA in a synthetic plasma matrix. DNA was extracted from these samples and characterized with different methods and multiple laboratories. The various extraction methods had differences in yield, perhaps because of differences in chemistry. Digital PCR assays were used to measure VAFs to compare results from different NGS methods. Comparable VAFs were observed across the different NGS methods. This multilaboratory assessment demonstrates that the new reference material is an appropriate tool to determine the analytical parameters of different measurement methods and to ensure their quality assurance.

Indexed as

Biomarkers, TumorCirculating Tumor DNADNA, NeoplasmLiquid BiopsyAllelesHigh-Throughput Nucleotide SequencingHumansNeoplasmsPolymerase Chain ReactionQuality Assurance, Health CareReference StandardsBiomarkers, TumorCirculating Tumor DNADNA, Neoplasm

Identifiers

PMID31055023
PMCPMC6626992

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.