T790M Mutation Testing in Blood by Different Methodologies
"T790M Mutation Testing in Blood by Different Methodologies"_RING Project
1 other identifier
observational
72
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedApril 8, 2020
April 1, 2020
12 months
November 24, 2017
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Cost of the different methodologies
At 12 months from the first inclusion
Specificity and sensitivity of each cfDNA method
At 12 months from the first inclusion
Other Outcomes (2)
Turnaround time of different methodologies
At 12 months from the first inclusion
Ease of use of different methodologies
At 12 months from the first inclusion
Study Arms (1)
Patients with T790M mutation
Patient who has progressed to Tyrosin Kinase inhibitors and has the mutation of the gen T790M
Interventions
Patients that received Tyrosin Kinase inhibitors and progressed
Eligibility Criteria
EGFR mutant non small cell lung cancer patients.
You may qualify if:
- 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.
You may not qualify if:
- Patients progressing to third generation EGFR TKIs (e.g. Osimertinib (TKI))
- No possibility of venipuncture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, 03804, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Complejo Hospitalario Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
H. Son Espases
Palma de Mallorca, Mallorca, 07014, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
H. Gen. Universitario de Alicante
Alicante, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, 05004, Spain
Instituto Universitario Dexeus
Barcelona, 08028, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario de Ciudad Real
Ciudad Real, 13005, Spain
ICO Girona -H. Dr. Josep Trueta
Girona, 17007, Spain
Hospital Clínico San Cecilio
Granada, 18012, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Complejo Asistencial Universitario de León
León, 24071, Spain
Hospital Lucus Agustí
Lugo, 27003, Spain
H.U. Puerta de Hierro
Madrid, 28035, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Universitario Sanchinarro
Madrid, 28050, Spain
H. Carlos Haya
Málaga, 29010, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital La Fe
Valencia, 46026, Spain
H. Gen. Univ. Valencia
Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Related Publications (1)
Romero 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: 33107189DERIVED
Related Links
Biospecimen
Blood samples in a EDTA tube will be drawn to extract DNA and analyse T790M mutation in NSCLC patients
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariano Provencio, PhD
Hospital Puerta del Hierro
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2017
First Posted
December 6, 2017
Study Start
March 1, 2018
Primary Completion
February 15, 2019
Study Completion
March 30, 2019
Last Updated
April 8, 2020
Record last verified: 2020-04