Clinical trial · Observational
T790M Mutation Testing in Blood by Different Methodologies
"T790M Mutation Testing in Blood by Different Methodologies"_RING Project
NCT03363139CI-TRIAL-00044549completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tirosin Kinase Inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with T790M mutation
- description
- Patient who has progressed to Tyrosin Kinase inhibitors and has the mutation of the gen T790M
- interventionNames
- Drug: Tirosin Kinase Inhibitors
Primary outcomes (1)
- measure
- Assess the agreement between qualitative methodologies
- timeFrame
- At 12 months from the first inclusion
- 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
Secondary outcomes (2)
- measure
- Cost of the different methodologies
- timeFrame
- At 12 months from the first inclusion
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRomero A, Jantus-Lewintre E, Garcia-Pelaez B, Royuela A, Insa A, Cruz P, Collazo A, Perez Altozano J, Vidal OJ, Diz P, Cobo M, Hernandez B, Vazquez Estevez S, Benitez G, Guirado M, Majem M, Bernabe R, Ortega AL, Blasco A, Bosch-Barrera J, Jurado JM, Garcia Gonzalez J, Viteri S, Garcia Giron C, Massuti B, Lopez Martin A, Rodriguez-Festa A, Calabuig-Farinas S, Molina-Vila MA, Provencio M. Comprehensive cross-platform comparison of methods for non-invasive EGFR mutation testing: results of the RING observational trial. Mol Oncol. 2021 Jan;15(1):43-56. doi: 10.1002/1878-0261.12832. Epub 2020 Nov 13. PMID 33107189