KEBI-Cyto Study
Research type
Research Study
Full title
Use of the Idylla platform for the detection of Epidermal Growth Factor Receptor, B-RAF and K-RAS proto-oncogene mutations in liquid based cytology specimens and blood plasma samples from patients with non small cell lung carcinoma and pancreatic adenocarcinoma.
IRAS ID
275530
Contact name
James Garvican
Contact email
Sponsor organisation
Royal Cornwall Hospital
Clinicaltrials.gov Identifier
NCT04236102, ClinicalTrials.gov
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
This study will investigate whether liquid based cytology specimens are a feasible alternative to formalin fixed paraffin embedded histology samples for detection of epidermal growth factor receptor(EGFR), KRAS and BRAF mutations in lung non small cell carcinomas and pancreatic adenocarcinomas using the Biocartis Idylla platform. The Biocartis Idylla is a fully automated, real time PCR based molecular diagnostic system. The Idylla carries out the entire analytical process from sample to result. This study will be based in the cytology department at the Royal Cornwall Hospital as part of a service improvement. It will use residual material from existing samples sent to the laboratory as part of the routine diagnostic service. It will be using existing material from patients diagnosed with lung non small cell carcinoma and pancreatic adenocarcinoma by cytology using the current, validated procedure, which uses formalin fixed paraffin embedded (FFPE)samples, over a 24 month period. Mutation results obtained using the validated procedure (FFPE) will be compared to those produced using the liquid based cytology (LBC)samples.
In addition to the cytology samples, for the prospective arm of the study, a blood sample will be taken at the time of the clinical procedure, using the existing cannula site. EGFR, KRAS and BRAF testing will be conducted on the blood plasma samples using the Biocartis Idylla Circulating Tumour DNA (CtDNA)kits. The results obtained will be analysed with the cytology sample results.Summary of results
The study involved 137 participants.
The overall sensitivities for mutation testing on the different preparations were; 100% for LBC samples, 98.4% for FFPE clot samples and 70% in blood plasma.
The prevalence of KRAS mutations in the pancreatic adenocarcinoma cohort was 75%. The most common KRAS mutations were G12V, G12D, G12R, 61, G12C respectively.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0152
Date of REC Opinion
23 Apr 2020
REC opinion
Favourable Opinion