T790M Mutation Testing in Blood by Different Methodologies
"T790M Mutation Testing in Blood by Different Methodologies"_RING Project
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Alicante, Spania
- H. Gen. Universitario de Alicante
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Barcelona, Spania, 08028
- Instituto Universitario Dexeus
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Barcelona, Spania, 08041
- Hospital de La Santa Creu i Sant Pau
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Burgos, Spania, 09006
- Hospital Universitario de Burgos
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Ciudad Real, Spania, 13005
- Hospital Universitario de Ciudad Real
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Girona, Spania, 17007
- ICO Girona -H. Dr. Josep Trueta
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Granada, Spania, 18012
- Hospital Clínico San Cecilio
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Jaén, Spania, 23007
- Complejo Hospitalario de Jaén
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León, Spania, 24071
- Complejo Asistencial Universitario de León
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Lugo, Spania, 27003
- Hospital Lucus Agusti
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Madrid, Spania, 28046
- Hospital La Paz
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Madrid, Spania, 28035
- H.U. Puerta de Hierro
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Madrid, Spania, 28050
- Hospital Universitario Sanchinarro
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Murcia, Spania, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Málaga, Spania, 29010
- H. Carlos Haya
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Sevilla, Spania, 41013
- Hospital Virgen Del Rocio
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Valencia, Spania, 46026
- Hospital La Fe
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Valencia, Spania, 46010
- Hospital Clínico Universitario de Valencia
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Valencia, Spania
- H. Gen. Univ. Valencia
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Valencia, Spania
- Hospital Arnau de Vilanova
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Ávila, Spania, 05004
- Hospital Nuestra Señora de Sonsoles
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A Coruña
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Santiago De Compostela, A Coruña, Spania, 15706
- Complejo Hospitalario Universitario de Santiago
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Alicante
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Alcoy, Alicante, Spania, 03804
- Hospital Virgen de los Lirios
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Elche, Alicante, Spania, 03203
- Hospital General Universitario de Elche
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Asturias
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Oviedo, Asturias, Spania
- Hospital Central de Asturias
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Gran Canaria
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Las Palmas de Gran Canaria, Gran Canaria, Spania, 35016
- Complejo Hospitalario Universitario Insular de Gran Canaria
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Madrid
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Alcalá De Henares, Madrid, Spania, 28805
- Hospital Principe de Asturias
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Leganés, Madrid, Spania, 28911
- Hospital Severo Ochoa
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Mallorca
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Palma de Mallorca, Mallorca, Spania, 07014
- H. Son Espases
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Navarra
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Pamplona, Navarra, Spania, 31008
- Complejo Hospitalario de Navarra
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Patients with T790M mutation
Patient who has progressed to Tyrosin Kinase inhibitors and has the mutation of the gen T790M
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Patients that received Tyrosin Kinase inhibitors and progressed
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assess the agreement between qualitative methodologies
Tidsramme: At 12 months from the first inclusion
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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
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At 12 months from the first inclusion
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cost of the different methodologies
Tidsramme: At 12 months from the first inclusion
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To compare the cost of the different methodologies
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At 12 months from the first inclusion
|
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Specificity and sensitivity of each cfDNA method
Tidsramme: At 12 months from the first inclusion
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To estimate the specificity and sensitivity of each cfDNA method.
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At 12 months from the first inclusion
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Turnaround time of different methodologies
Tidsramme: At 12 months from the first inclusion
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To compare turnaround time of the different methodologies
|
At 12 months from the first inclusion
|
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Ease of use of different methodologies
Tidsramme: At 12 months from the first inclusion
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To compare the ease of use of the different methodologies
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At 12 months from the first inclusion
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mariano Provencio, PhD, Hospital Puerta del Hierro
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- GECP 17/03_RING
Plan for individuelle deltakerdata (IPD)
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