NSCLC Stage IV Clinical Trial
Official title:
"T790M Mutation Testing in Blood by Different Methodologies"_RING Project
Three laboratories will participate in the study. Each laboratory will analyze the same samples by different methodologies according to the flow indicated in figure 1. This design will allow comparing the agreement performance of different methods available for T790M identification in circulating-free DNA isolated from peripheral blood.
Three blood samples per patient will be collected once at the time of progression, assessed
by CT Scans according to RECIST criteria v.1.1 and before the patients start a new treatment
The blood samples (5-10 mL each) will be collected in one Cell-Free DNA BCT Streck® and 2 PTT
EDTA K2 (BECTON DICKINSON) collection tubes.
All samples will be labeled properly with the patient identification number and date of
extraction. These samples will be stored and distributed through the 3 participating
laboratories until completion of all the analyses, according to the flowchart in Figure 1.
These samples will be registered in the samples collection of the Institute of Health Carlos
III Registry. These samples will be kept in each participant laboratory after the completion
of the RING study and the patient will be informed of that in the patient information sheet
and informed consent.
cfDNA will be extracted using as starting volume 1 ml of plasma with a Maxwell® RSC
instrument (Promega), using the Maxwell® RSC cfDNA Plasma Kit (MR), as specified by the
manufacturer or with a Qiasymphony instrument (Qiagen company). Additionally, for BEAMing
analysis, 3 ml of plasma will be used for cfDNA isolation using the the QIAamp® Circulating
Nucleic Acid Kit (Qiagen company), following the manufacturer instructions.
Circulating free DNA from peripheral blood sample is an adequate source for T790M resistance
mutation testing. However, comparison across different platforms has been scarcely reported.
Discordant results for EGFR biomarker testing could impact patient management.
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