The Detection of EGFR Mutations in Liquid Based Cytology Samples

NCT04086680 | Completed

• 1 other identifier: 2019.RCHT.24
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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) mutations in lung adenocarcinoma using the Biocartis Idylla platform. The Biocartis Idylla is a fully automated, real-time PCR based molecular diagnostics system. The Idylla carries out the entire analytical process from sample to result. This study will be based in the cytology department at 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 service. It will use existing material from patients diagnosed with lung adenocarcinoma by cytology using the current, validated procedure which uses formalin-fixed paraffin embedded (FFPE) samples over a 10 month period. EGFR mutation results obtained using the validated procedure (formalin fixed paraffin embedded) will be compared to those produced using liquid based cytology samples.

Conditions

Adenocarcinoma of Lung

Outcome Measures

Primary Outcomes (1)

• Significance of using liquid based cytology samples for EGFR mutation detection using the Idylla platform (in comparison to the use of FFPE samples)

  The relative sensitivity and specificity will be calculated. Significance of use of liquid based cytology samples will be calculated using McNemars chi-squared test.

  10 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from patients who have been diagnosed with lung adenocarcinoma by the cytology laboratory at Royal Cornwall Hospital Treliske using the current validated method on formalin-fixed paraffin embedded samples.

You may qualify if:

• Diagnosis of lung adenocarcinoma by the cytology laboratory at Royal Cornwall Hospital Trust using the current, validated method on formalin-fixed paraffin embedded samples within the time period of the study. This will include both patients with wild type lung adenocarcinoma and also patients with lung adenocarcinoma with EGFR mutations.

You may not qualify if:

• Samples received by the cytology laboratory following the sampling procedures that are not diagnosed as lung adenocarcinoma during the time period of the study.

Sponsors & Collaborators

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

Study Sites (1)

Cytopathology Laboratory Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 11, 2019
• Study Start: May 7, 2019
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: June 22, 2020

Record last verified: 2019-06

Locations

GB (1)