Evidence map›Paper›PMID 28188106›Full record

ArticleThe Journal of molecular diagnostics : JMD2017

Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial.

Chih-Jian Lih, Robin D Harrington, David J Sims, Kneshay N Harper, Courtney H Bouk, Vivekananda Datta, Jonathan Yau, Rajesh R Singh, Mark J Routbort, Rajyalakshmi Luthra and 18 more

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05372081 (Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer), which is not on this map. Cited by 106 papers.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed
6.5field-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.

NCT05372081 completednot on this mapstarted 2022, after this paper: background citation

Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer

TypeobservationalSponsorHellenic Cooperative Oncology GroupRan2022 to 2025Enrolled200ConditionsNon-Small Cell Carcinoma of Lung, TNM Stage 4ArmsDigital platform
3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 153 citations in OpenAlex.

  1. Trial
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  3. Phase II Study of Vismodegib in Patients WithJCO precision oncology · 2025
    Trial
  4. PIK3CB Inhibitor GSK2636771 in Cancers WithJCO precision oncology · 2025
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  9. Phase II Trial of Afatinib in Patients WithJCO precision oncology · 2024
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  15. Phase II Study of Palbociclib (PD-0332991) in CCND1, 2, or 3 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1B.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
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  19. Phase II Study of Copanlisib in Patients With Tumors WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 6 institutions in 1 country.

Chih-Jian LihMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Robin D HarringtonMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
David J SimsMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Kneshay N HarperMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Courtney H BoukMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Vivekananda DattaMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Jonathan YauDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Rajesh R SinghDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Mark J RoutbortDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Rajyalakshmi LuthraDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Keyur P PatelDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Geeta S ManthaDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Savitri KrishnamurthyDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Karyn RonskiDepartment of Pathology, School of Medicine, Yale University, New Haven, Connecticut.
Zenta WaltherDepartment of Pathology, School of Medicine, Yale University, New Haven, Connecticut.
Karin E FinbergDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Sandra CanosaDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Hayley RobinsonDepartment of Pathology, Massachusetts General Hospital, Boston, Massachusetts.
Amelia RaymondDepartment of Pathology, Massachusetts General Hospital, Boston, Massachusetts.
Long P LeDepartment of Pathology, Massachusetts General Hospital, Boston, Massachusetts.
Lisa M McShaneDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.
Eric C PolleyDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.
Barbara A ConleyDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.
James H DoroshowDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.
A John IafrateDepartment of Pathology, Massachusetts General Hospital, Boston, Massachusetts.
Jeffrey L SklarDepartment of Pathology, School of Medicine, Yale University, New Haven, Connecticut.
Stanley R HamiltonDivision of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
P Mickey WilliamsMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland. Electronic address: mickey.williams@nih.gov.
The University of Texas MD Anderson Cancer Center · USFrederick National Laboratory for Cancer Research · USMassachusetts General Hospital · USNational Cancer Institute · USYale University · USLeidos (United States) · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Phase 01 Clinical TrialsZIABC011078 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI DOROSHOW, JAMES · 2009 to 2025
$9.0M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001ENCI NIH HHS U10 CA180820NCI NIH HHS U24 CA196172
6 · The paper itself

Abstract

The National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) trial is a national signal-finding precision medicine study that relies on genomic assays to screen and enroll patients with relapsed or refractory cancer after standard treatments. We report the analytical validation processes for the next-generation sequencing (NGS) assay that was tailored for regulatory compliant use in the trial. The Oncomine Cancer Panel assay and the Personal Genome Machine were used in four networked laboratories accredited for the Clinical Laboratory Improvement Amendments. Using formalin-fixed paraffin-embedded clinical specimens and cell lines, we found that the assay achieved overall sensitivity of 96.98% for 265 known mutations and 99.99% specificity. High reproducibility in detecting all reportable variants was observed, with a 99.99% mean interoperator pairwise concordance across the four laboratories. The limit of detection for each variant type was 2.8% for single-nucleotide variants, 10.5% for insertion/deletions, 6.8% for large insertion/deletions (gap ≥4 bp), and four copies for gene amplification. The assay system from biopsy collection through reporting was tested and found to be fully fit for purpose. Our results indicate that the NCI-MATCH NGS assay met the criteria for the intended clinical use and that high reproducibility of a complex NGS assay is achievable across multiple clinical laboratories. Our validation approaches can serve as a template for development and validation of other NGS assays for precision medicine.

Indexed as

High-Throughput Nucleotide SequencingClinical Trials as TopicComputational BiologyGenetic VariationGenomicsHumansNeoplasmsQuality Assurance, Health CareQuality ControlReproducibility of ResultsSensitivity and SpecificityWorkflow

Identifiers

PMID28188106
PMCPMC5397672
OpenAlexW2586898085

What OpenQuestion holds

Textmetadata
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.