T790M Mutation Testing in Blood by Different Methodologies
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|ClinicalTrials.gov Identifier: NCT03363139|
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment|
|NSCLC Stage IV||Drug: Tirosin Kinase Inhibitors|
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|
|Actual Enrollment :||72 participants|
|Official Title:||"T790M Mutation Testing in Blood by Different Methodologies"_RING Project|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||February 15, 2019|
|Actual Study Completion Date :||March 30, 2019|
Patients with T790M mutation
Patient who has progressed to Tyrosin Kinase inhibitors and has the mutation of the gen T790M
Drug: Tirosin Kinase Inhibitors
Patients that received Tyrosin Kinase inhibitors and progressed
Other Name: TKI
- Assess the agreement between qualitative methodologies [ Time Frame: At 12 months from the first inclusion ]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
- Cost of the different methodologies [ Time Frame: At 12 months from the first inclusion ]To compare the cost of the different methodologies
- Specificity and sensitivity of each cfDNA method [ Time Frame: At 12 months from the first inclusion ]To estimate the specificity and sensitivity of each cfDNA method.
- Turnaround time of different methodologies [ Time Frame: At 12 months from the first inclusion ]To compare turnaround time of the different methodologies
- Ease of use of different methodologies [ Time Frame: At 12 months from the first inclusion ]To compare the ease of use of the different methodologies
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363139
|Principal Investigator:||Mariano Provencio, PhD||Hospital Puerta del Hierro|