Idylla EGFR Lung Trial

Study Overview
=================
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.

Official Title
-----------------
Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care

Conditions
-----------------
Lung Cancer, Technology, Oncology

Intervention / Treatment
-----------------
* Diagnostic Test: Idylla EGFR Mutation Test


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer<br>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. | Diagnostic Test: Idylla EGFR Mutation Test<br>* This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Idylla EGFR Mutation Test | The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples. | Retrospective tissue samples no longer than 5 years old | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Protean BioDiagnostics