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Report for Clinical Trial NCT03363139

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

"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.

NCT03363139 NSCLC Stage IV

1 Interventions

Name: Tirosin Kinase Inhibitors

Description: Patients that received Tyrosin Kinase inhibitors and progressed
Type: Drug
Group Labels: 1

Patients with T790M mutation


Primary Outcomes

Description: 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

Measure: Assess the agreement between qualitative methodologies

Time: At 12 months from the first inclusion

Secondary Outcomes

Description: To compare the cost of the different methodologies

Measure: Cost of the different methodologies

Time: At 12 months from the first inclusion

Description: To estimate the specificity and sensitivity of each cfDNA method.

Measure: Specificity and sensitivity of each cfDNA method

Time: At 12 months from the first inclusion

Other Outcomes

Description: To compare turnaround time of the different methodologies

Measure: Turnaround time of different methodologies

Time: At 12 months from the first inclusion

Description: To compare the ease of use of the different methodologies

Measure: Ease of use of different methodologies

Time: At 12 months from the first inclusion

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 T790M

"T790M Mutation Testing in Blood by Different Methodologies"_RING Project. --- T790M ---

T790M Mutation Testing in Blood by Different Methodologies Three laboratories will participate in the study. --- T790M ---

This design will allow comparing the agreement performance of different methods available for T790M identification in circulating-free DNA isolated from peripheral blood. --- T790M ---

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. --- T790M ---

Circulating free DNA from peripheral blood sample is an adequate source for T790M resistance mutation testing. --- T790M ---



HPO Nodes