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NCT04962191 Clinical Trial

Idylla EGFR Lung Trial

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04962191
Other study ID # R20-00012
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2021
Est. completion date January 2023

Study information
Verified date July 2021
Source Protean BioDiagnostics
Contact Hannah Park, BS
Phone 754-242-9682
Email hannah.park@proteanbiodx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date January 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Idylla EGFR Mutation Test
This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.

Locations
Country Name City State
United States 6555 Sanger Rd, Suite 260 Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
Anthony Magliocco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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