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T790M Mutation Testing in Blood by Different Methodologies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363139
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group

Brief 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.

Condition or disease Intervention/treatment
NSCLC Stage IV Drug: Tirosin Kinase Inhibitors

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.

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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 Name: TKI




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cost of the different methodologies [ Time Frame: At 12 months from the first inclusion ]
    To compare the cost of the different methodologies

  2. 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.


Other Outcome Measures:
  1. Turnaround time of different methodologies [ Time Frame: At 12 months from the first inclusion ]
    To compare turnaround time of the different methodologies

  2. 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
Blood samples in a EDTA tube will be drawn to extract DNA and analyse T790M mutation in NSCLC patients


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
EGFR mutant non small cell lung cancer patients.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
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Principal Investigator: Mariano Provencio, PhD Hospital Puerta del Hierro
Additional Information:
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Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT03363139    
Other Study ID Numbers: GECP 17/03_RING
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No