Idylla EGFR Lung Trial

• Conditions: Technology; Oncology; Lung Cancer
• Interventions: Diagnostic Test: Idylla EGFR Mutation Test

• Registration Number: NCT04962191
• Lead Sponsor: Anthony Magliocco

Brief Summary

This retrospective, observational study will compare the results of a BioCartis' EGFR mutation test on the Idylla platform with test results from SoC pathology results from tissue biopsies in the same setting. A comparable rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies. Up to 150 samples will be tested and compared with existing results.

Detailed Description

This study will compare the results of a BioCartis' EGFR mutation test on theIdylla platform with test results from standard of care (SoC) pathology results from tissue biopsies. The Idylla™ EGFR Mutation Test, performed on the BioCartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of exon 18, exon 20, and exon 21 mutations. Additionally, exon 19 deletions and exon 20 insertions in the EGFR oncogene. A rapid testing platform for EGFR may serve as a more accessible means to diagnose, and overall, more patients treated successfully with targeted therapies.

Study Timeline

• Study First Submitted: 2020-12-17
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Study Start: 2021-08
• Primary Completion: 2022-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients diagnosed with primary lung cancer
• Data from primary diagnosis must be included in pathology report or data entry.
• Detailed pathology report included for all samples

Exclusion Criteria

• Limited or no tissue available
• Only tissue available is from fine needle aspiration
• Tissue blocks older than 5 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung Cancer	Idylla EGFR Mutation Test	The Idylla EGFR Mutation Test, performed on the BioCartis Idylla System, is an in vitro diagnostic test for the qualitative detection of exon mutations. One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. This study can help test the BioCartis Idylla System against standard of care (SoC) pathology results from tissue biopsies in the same setting, ultimately being able to diagnose with a fraction of the tissue previously needed.

Primary Outcome Measures

Name	Time	Method
Idylla EGFR Mutation Test	Retrospective tissue samples no longer than 5 years old	The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples.

Trial Locations

Locations (1)

6555 Sanger Rd, Suite 260; 🇺🇸 Orlando, Florida, United States