T790M Mutation Testing in Blood by Different Methodologies

NSCLC Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363139
• Other study ID #: GECP 17/03_RING
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2020
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 30, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC Stage IV

Intervention

Drug:
• Tirosin Kinase Inhibitors
Patients that received Tyrosin Kinase inhibitors and progressed

Locations

Country	Name	City	State
Spain	Hospital Príncipe de Asturias	Alcalá De Henares	Madrid
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	H. Gen. Universitario de Alicante	Alicante
Spain	Hospital Nuestra Señora de Sonsoles	Ávila
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Instituto Universitario Dexeus	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario de Ciudad Real	Ciudad Real
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	ICO Girona -H. Dr. Josep Trueta	Girona
Spain	Hospital Clínico San Cecilio	Granada
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Complejo Hospitalario Universitario Insular de Gran Canaria	Las Palmas de Gran Canaria	Gran Canaria
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital Lucus Agustí	Lugo
Spain	H.U. Puerta de Hierro	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Sanchinarro	Madrid
Spain	H. Carlos Haya	Málaga
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	H. Son Espases	Palma de Mallorca	Mallorca
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela	A Coruña
Spain	Hospital Virgen del Rocío	Sevilla
Spain	H. Gen. Univ. Valencia	Valencia
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Turnaround time of different methodologies	To compare turnaround time of the different methodologies	At 12 months from the first inclusion
Other	Ease of use of different methodologies	To compare the ease of use of the different methodologies	At 12 months from the first inclusion
Primary	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	At 12 months from the first inclusion
Secondary	Cost of the different methodologies	To compare the cost of the different methodologies	At 12 months from the first inclusion
Secondary	Specificity and sensitivity of each cfDNA method	To estimate the specificity and sensitivity of each cfDNA method.	At 12 months from the first inclusion

External Links

•   Grupo Español de Cáncer de Pulmón