T790M Mutation Testing in Blood by Different Methodologies

Spanish Lung Cancer Group72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

NSCLC Stage IV

Interventions

Tirosin Kinase InhibitorsDRUG

Patients that received Tyrosin Kinase inhibitors and progressed

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with EGFR mutant, stage IIIB and IV non small cell lung cancer and who have progressed assessed by CT Scans according to RECIST criteria v.1.1 to first or second generation EGFR tyrosine kinase inhibitors (TKIs) (e.g. gefitinib, erlotinib, afatinib) including patients who received a chemotherapy line before TKI treatment. Samples have to be drawn before the patient starts a new treatment, * Patients have to sign the informed consent of the study * Patients aged ≥ 18 years. Exclusion Criteria: * Patients progressing to third generation EGFR TKIs (e.g. Osimertinib (TKI)) * No possibility of venipuncture.

Locations (30)

Outcomes

Primary Outcomes

Assess the agreement between qualitative methodologies

To evaluate the agreement performance of different methodologies available in Spain for T790M identification in circulating-free DNA isolated from blood collected at the time of progression on a first or second generation TKI

Time frame: At 12 months from the first inclusion

Secondary Outcomes

Cost of the different methodologies

To compare the cost of the different methodologies

Time frame: At 12 months from the first inclusion

Specificity and sensitivity of each cfDNA method

To estimate the specificity and sensitivity of each cfDNA method.

Time frame: At 12 months from the first inclusion

Data from ClinicalTrials.gov

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