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Report for Clinical Trial NCT03309462

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Analysis of Re-biopsy Specimens in Advanced Non-small Cell Lung Cancer With Acquired Resistance of Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Targeted Therapy

The objective of the study is to reveal the acquired resistance mechanism of the first and second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in tissue and plasma using Next Generation Sequencing (NGS) and the difference of ctDNA in plasma and DNA in biopsy samples is compared and the consistency of two samples was observed. At the same time, the sensitivity, specificity and the consistency of detecting T790M mutation using ddPCR, Cobas and NGS were compared.

NCT03309462 Lung Cancer
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

1 Interventions

Name: Miseq sequencer

Description: The sequencer will be used to detect the gene mutations of the re-biopsy tissue samples and peripheral blood samples obtained from patients.
Type: Device
Group Labels: 2

Peripheral blood sample Re-biopsy tissue sample


Primary Outcomes

Description: differences of gene mutation between re-biopsy tissue sample and peripheral blood sample will be tested by NGS

Measure: Compare the differences of gene mutation between tissue sample and peripheral blood sample by NGS

Time: up to one year

Purpose: Diagnostic

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 T790M

At the same time, the sensitivity, specificity and the consistency of detecting T790M mutation using ddPCR, Cobas and NGS were compared. --- T790M ---

The tissue will be divided into two parts, one part was sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed NSCLC, the other part will be extracted with DNA and performed NGS for the qualified DNA sample and using Cobas to detect the T790M mutation. --- T790M ---



HPO Nodes


HPO: