KEBI-Cyto Study - Use of the Biocartis Idylla

NCT04236102 | Completed

• 1 other identifier: 2019.RCHT.111
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Adenocarcinoma; Lung Cancer

Outcome Measures

Primary Outcomes (3)

• The number of participants with negative and positive mutation status for KRAS, EGFR and BRAF in LBC samples detected using the BioCartis Idylla Platform real time PCR kits.

  1\. Can the Idylla platform provide a standardised and effective method for detecting EGFR, KRAS and BRAF mutations in liquid based cytology samples for patients with lung and pancreatic cancer. Mutation detection increases the treatment options for patients.

  24 months

• The number of patients with a positive KRAS mutation status in Cytolgy clot samples reported as pancreatic adenocarcinoma, using the Biocartis Idylla platform real time PCR kits.

  2\. Establish the mutation prevalence in population served by the Royal Cornwall Hospital. This could provide an avenue for drug development to treat pancreatic cancers

  24 months

• The number of participants with negative and positive mutation status for KRAS, EGFR and BRAF in blood plasma samples detected using the BioCartis Idylla Platform real time PCR kits.

  3\. Testing for mutations in the blood samples and directly comparing it with mutations seen in the cytology samples, will provide valuable information in the reliance of blood tests for cancer diagnosis. Potentially eliminating the need for invasive procedures in the future.

  24 months

Study Arms (3)

EGFR, KRAS, BRAF Lung adenocarcinoma LBC

EXPERIMENTAL

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.

Diagnostic Test: Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples

KRAS Pancreatic adenocarcinoma

EXPERIMENTAL

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.

Diagnostic Test: Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples

EGFR, KRAS, BRAF Blood plasma

EXPERIMENTAL

Will involve a blood sample being taken at the time of the procedure from patients that have a clinical suspicion of having lung or pancreatic cancer. The single blood sample will be taken from the cannula inserted for the procedure. The blood sample will be processed using the Biocartis Idylla ™ circulating tumour cell cartridges (EFGR, KRAS and BRAF for lung and KRAS for pancreas).

Diagnostic Test: Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples

Interventions

Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples DIAGNOSTIC_TEST

Automated real time PCR mutation analysis - 1. Can the Idylla platform provide a standardised and effective method for detecting EGFR, KRAS and BRAF mutations in blood and liquid based cytology samples for patients with lung and pancreatic cancer. Mutation detection increases the treatment options for patients.

EGFR, KRAS, BRAF Blood plasma; EGFR, KRAS, BRAF Lung adenocarcinoma LBC; KRAS Pancreatic adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other malignancies (Not non small cell lung carcinoma or pancreatic adenocarcinoma)
• Benign diagnosis
• Patients under the age of 18

Sponsors & Collaborators

• Royal Cornwall Hospitals Trust: lead
• Biocartis NV: collaborator

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Related Publications (4)

• Zhao 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 BACKGROUND

• De 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 RESULT

• Hadano 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 RESULT

• Sausen 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 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Genes, ras

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena

Study Officials

• James Garvican

  Royal Cornwall Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 22, 2020
• Study Start: July 7, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: March 29, 2023

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)