Clinical trial · Interventional
KEBI-Cyto Study - Use of the Biocartis Idylla
Use of the Biocartis 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
NCT04236102CI-TRIAL-00065143completedN/AClinicalTrials.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)
Use of the Biocartis 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- EGFR, KRAS, BRAF Lung adenocarcinoma LBC
- description
- Will use residual material from existing LBC cytology samples sent to the laboratory. Routine testing will take priority. Cases identified as non small cell lung carcinoma will have the residual LBC sample tested on the Idylla platform for EGFR, KRAS and BRAF. The EGFR, KRAS and BRAF mutation results obtained using the routine diagnostic procedure (FFPE samples) will be compared to those produced using the LBC samples.
- interventionNames
- Diagnostic Test: Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples
- type
- EXPERIMENTAL
- label
- KRAS Pancreatic adenocarcinoma
- description
- Will involve testing archived FFPE clot samples from confirmed pancreatic adenocarcinoma patients since 2014 (Approximately 20 cases per year). KRAS testing will be performed using the Idylla platform to establish if there is a KRAS codon 12 mutation present in 94% percent of the cases reported at RCHT. Patients will have consented to the use of their tissue at the time of procedure. Prospectively new patients diagnosed with pancreatic adenocarcinoma will have KRAS testing on the FFPE clot made as part of the routine diagnostic work up and KRAS testing on the LBC sample.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytological / histological diagnosis of non small cell lung carcinoma or pancreatic adenocarcinoma * Patients of any gender ethnicity or socioeconomic grouping * Patients over the age of 18 years Exclusion Criteria: * Other malignancies (Not non small cell lung carcinoma or pancreatic adenocarcinoma) * Benign diagnosis * Patients under the age of 18
References
Publications (4)
- BACKGROUNDZhao H, Qiu T, Guo H, Ying J, Li J, Zhang Z. Detection of EGFR and KRAS gene mutations using suspension liquid-based cytology specimens in metastatic lung adenocarcinoma. Oncotarget. 2017 Nov 20;8(63):106685-106692. doi: 10.18632/oncotarget.22530. eCollection 2017 Dec 5. PMID 29290981
- RESULTDe Luca C, Gragnano G, Pisapia P, Vigliar E, Malapelle U, Bellevicine C, Troncone G. EGFR mutation detection on lung cancer cytological specimens by the novel fully automated PCR-based Idylla EGFR Mutation Assay. J Clin Pathol. 2017 Apr;70(4):295-300. doi: 10.1136/jclinpath-2016-203989. Epub 2016 Aug 19. PMID 27543600
- RESULTHadano N, Murakami Y, Uemura K, Hashimoto Y, Kondo N, Nakagawa N, Sueda T, Hiyama E. Prognostic value of circulating tumour DNA in patients undergoing curative resection for pancreatic cancer. Br J Cancer. 2016 Jun 28;115(1):59-65. doi: 10.1038/bjc.2016.175. Epub 2016 Jun 9. PMID 27280632
- RESULTSausen M, Phallen J, Adleff V, Jones S, Leary RJ, Barrett MT, Anagnostou V, Parpart-Li S, Murphy D, Kay Li Q, Hruban CA, Scharpf R, White JR, O'Dwyer PJ, Allen PJ, Eshleman JR, Thompson CB, Klimstra DS, Linehan DC, Maitra A, Hruban RH, Diaz LA Jr, Von Hoff DD, Johansen JS, Drebin JA, Velculescu VE. Clinical implications of genomic alterations in the tumour and circulation of pancreatic cancer patients. Nat Commun. 2015 Jul 7;6:7686. doi: 10.1038/ncomms8686. PMID 26154128