Trial reportThe Journal of molecular diagnostics : JMD2016
Analytical Validation and Application of a Targeted Next-Generation Sequencing Mutation-Detection Assay for Use in Treatment Assignment in the NCI-MPACT Trial.
Trial report in The Journal of molecular diagnostics : JMD, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01827384 (Molecular Profiling-Based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors), which is not on this map. Cited by 23 papers.
What it found
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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.
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.
Molecular Profiling-Based Assignment of Cancer Therapy for Patients With Advanced Solid Tumors
Who cites it
23 citing papers in PubMed, 45 citations in OpenAlex.
- Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT): A Randomized Multicenter Phase II Trial.JCO precision oncology · 2021Trial
- The Application of Control Materials for Ongoing Quality Management of Next-Generation Sequencing in a Clinical Genetic Laboratory.Medicina (Kaunas, Lithuania) · 2021Review
- Development and validation of a multigene variant profiling assay to guide targeted and immuno therapy selection in solid tumors.PloS one · 2021Article
- An overview of precision oncology basket and umbrella trials for clinicians.CA: a cancer journal for clinicians · 2020Review
- Quantification of DNA through the NanoDrop Spectrophotometer: Methodological Validation Using Standard Reference Material and Sprague Dawley Rat and Human DNA.International journal of analytical chemistry · 2020Article
- Development and interlaboratory evaluation of a NIST Reference Material RM 8366 for EGFR and MET gene copy number measurements.Clinical chemistry and laboratory medicine · 2019Article
- Biomarker-Driven Oncology Clinical Trials: Key Design Elements, Types, Features, and Practical Considerations.JCO precision oncology · 2019Review
- Analytical Validation of Clinical Whole-Genome and Transcriptome Sequencing of Patient-Derived Tumors for Reporting Targetable Variants in Cancer.The Journal of molecular diagnostics : JMD · 2018Article
- What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?Journal of oncology practice · 2018Article
- Current and Future Molecular Testing in NSCLC, What Can We Expect from New Sequencing Technologies?Journal of clinical medicine · 2018Review
- Quality Control of Next-generation Sequencing-basedJournal of Cancer · 2018Article
- A robust targeted sequencing approach for low input and variable quality DNA from clinical samples.NPJ genomic medicine · 2018Article
- Rapid, ultra low coverage copy number profiling of cell-free DNA as a precision oncology screening strategy.Oncotarget · 2017Article
- Precision Medicine Requires Precision Laboratories.The Journal of molecular diagnostics : JMD · 2017Article
- Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial.The Journal of molecular diagnostics : JMD · 2017Article
- Next-Generation Sequencing in Oncology: Genetic Diagnosis, Risk Prediction and Cancer Classification.International journal of molecular sciences · 2017Review
- Precision Oncology Medicine: The Clinical Relevance of Patient-Specific Biomarkers Used to Optimize Cancer Treatment.Journal of clinical pharmacology · 2016Review
- Development and Characterization of Reference Materials for Genetic Testing: Focus on Public Partnerships.Annals of laboratory medicine · 2016Review
- Certified DNA Reference Materials to Compare HER2 Gene Amplification Measurements Using Next-Generation Sequencing Methods.The Journal of molecular diagnostics : JMD · 2016Article
- Plasmid-Based Materials as Multiplex Quality Controls and Calibrators for Clinical Next-Generation Sequencing Assays.The Journal of molecular diagnostics : JMD · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 2 institutions in 1 country.
Funding
Abstract
Robust and analytically validated assays are essential for clinical studies. We outline an analytical validation study of a targeted next-generation sequencing mutation-detection assay used for patient selection in the National Cancer Institute Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT) trial (NCT01827384). Using DNA samples from normal or tumor cell lines and xenografts with known variants, we assessed the sensitivity, specificity, and reproducibility of the NCI-MPACT assay in five variant types: single-nucleotide variants (SNVs), SNVs at homopolymeric (HP) regions (≥3 identical bases), small insertions/deletions (indels), large indels (gap ≥4 bp), and indels at HP regions. The assay achieved sensitivities of 100% for 64 SNVs, nine SNVs at HP regions, and 11 large indels, 83.33% for six indels, and 93.33% for 15 indels at HP regions. Zero false positives (100% specificity) were found in 380 actionable mutation loci in 96 runs of haplotype map cells. Reproducibility analysis showed 96.3% to 100% intraoperator and 98.1% to 100% interoperator mean concordance in detected variants and 100% reproducibility in treatment selection. To date, 38 tumors have been screened, 34 passed preanalytical quality control, and 18 had actionable mutations for treatment assignment. The NCI-MPACT assay is well suited for its intended investigational use and can serve as a template for developing next-generation sequencing assays for other cancer clinical trial applications.
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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.