Evidence map›Paper›PMID 39385536›Full record

ArticleCancer medicine2024

Analytical and clinical validation of a NGS panel in detecting targetable variants from ctDNA of metastatic NSCLC patients.

Feifei Fan, Guozhong Jiang, Juan Lv, Hongmin Wang, Wenjie Li, Chenglin Liu, Yu Zhao, Zhou Zhang, Haiwei Du, Zhihong Zhang and 2 more

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

12 authors.

Feifei FanDepartment of Respiratory Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Guozhong JiangDepartment of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.ORCID https://orcid.org/0000-0001-6306-726X
Juan LvBurning Rock Biotech, Guangzhou, China.
Hongmin WangDepartment of Respiratory Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Wenjie LiBurning Rock Biotech, Guangzhou, China.
Chenglin LiuBurning Rock Biotech, Guangzhou, China.
Yu ZhaoBurning Rock Biotech, Guangzhou, China.
Zhou ZhangBurning Rock Biotech, Guangzhou, China.
Haiwei DuBurning Rock Biotech, Guangzhou, China.
Zhihong ZhangBurning Rock Biotech, Guangzhou, China.
Xiangnan LiDepartment of Thoracic Surgery and Lung Transplantation, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Wen-Cai LiDepartment of Pathology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.ORCID https://orcid.org/0000-0002-6115-1246

Funding

National Natural Science Foundation of China 82172941
6 · The paper itself

Abstract

backgroundCirculating tumor DNA (ctDNA) has emerged as a promising biomarker for noninvasive cancer diagnostics, particularly in the context of metastatic non-small-cell lung cancer (NSCLC). Detecting targetable variants through ctDNA analysis offers the potential to guide treatment decisions, especially in cases where tissue samples are insufficient or unavailable.

methodIn this study, we developed and validated a next-generation sequencing panel targeting 101 cancer-related genes (101-test) to detect somatic variants in ctDNA from a large cohort of Chinese patients with metastatic NSCLC. The performance of the 101-test was assessed by evaluating its limit of detection (LOD), accuracy, and precision in identifying molecular variants. Additionally, the concordance between ctDNA and tissue samples for detecting targetable variants was analyzed in 904 patients.

resultsThe 101-test demonstrated a LOD of 0.38% for single-nucleotide variants (SNVs), 0.33% for insertions and deletions (InDels), and 0.33% for fusions. Sensitivity was 98.3% for SNVs, 100% for InDels, and 100% for fusions when compared to digital droplet PCR (ddPCR)/breakpoint PCR reference methods. The by-variant sensitivity for somatic variants was 97.5%, with a specificity of 99.9% between tumor-only and tumor-normal analyses. In a real-world cohort, the concordance between ctDNA and tissue samples for identifying targetable variants was 72.2% (457/633). Notably, the EGFR S768I variant, recently recommended by clinical guidelines, achieved an 80% concordance rate. Furthermore, 4.3% of patients (27/633) with targetable variants were identified exclusively through ctDNA testing.

conclusionThe ctDNA-based 101-test is a highly sensitive and specific tool for detecting targetable variants in metastatic NSCLC, particularly in cases with insufficient tissue samples. The findings support the use of ctDNA testing as a reliable and complementary method to traditional tissue-based molecular analysis, enhancing the precision of treatment strategies for NSCLC patients.

Indexed as

Biomarkers, TumorCarcinoma, Non-Small-Cell LungCirculating Tumor DNAHigh-Throughput Nucleotide SequencingLung NeoplasmsAdultAgedAged, 80 and overFemaleHumansLimit of DetectionMaleMiddle AgedMutationPolymorphism, Single NucleotideSensitivity and SpecificityBiomarkers, TumorCirculating Tumor DNAcirculating tumor DNAconcordancenext‐generation sequencingtargetable variantstissue sample

Identifiers

PMID39385536
PMCPMC11464656

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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.