T790M Mutation Testing in Blood by Different Methodologies

April 7, 2020 updated by: Spanish Lung Cancer Group

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • H. Gen. Universitario de Alicante
      • Barcelona, Spain, 08028
        • Instituto Universitario Dexeus
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Ciudad Real, Spain, 13005
        • Hospital Universitario de Ciudad Real
      • Girona, Spain, 17007
        • ICO Girona -H. Dr. Josep Trueta
      • Granada, Spain, 18012
        • Hospital Clínico San Cecilio
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaen
      • León, Spain, 24071
        • Complejo Asistencial Universitario de León
      • Lugo, Spain, 27003
        • Hospital Lucus Agustí
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28035
        • H.U. Puerta de Hierro
      • Madrid, Spain, 28050
        • Hospital Universitario Sanchinarro
      • Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Málaga, Spain, 29010
        • H. Carlos Haya
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
      • Valencia, Spain, 46026
        • Hospital La Fe
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain
        • H. Gen. Univ. Valencia
      • Valencia, Spain
        • Hospital Arnau de Vilanova
      • Ávila, Spain, 05004
        • Hospital Nuestra Senora de Sonsoles
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Hospital Virgen de los Lirios
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Gran Canaria
      • Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
        • Complejo Hospitalario Universitario Insular de Gran Canaria
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Hospital Principe de Asturias
      • Leganés, Madrid, Spain, 28911
        • Hospital Severo Ochoa
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07014
        • H. Son Espases
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

EGFR mutant non small cell lung cancer patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 12 months from the first inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of the different methodologies
Time Frame: At 12 months from the first inclusion
To compare the cost of the different methodologies
At 12 months from the first inclusion
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.
At 12 months from the first inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turnaround time of different methodologies
Time Frame: At 12 months from the first inclusion
To compare turnaround time of the different methodologies
At 12 months from the first inclusion
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
At 12 months from the first inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Lung Cancer Group

Investigators

  • Principal Investigator: Mariano Provencio, PhD, Hospital Puerta del Hierro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • GECP 17/03_RING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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