Recruiting

Idylla EGFR

Sponsor:

Anthony Magliocco

Code:

NCT04962191

Conditions

Lung Cancer

Technology

Oncology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Idylla EGFR Mutation Test

Study Details

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.

Conditions

Lung Cancer

Technology

Oncology

Study ID

NCT04962191

Start date

Aug, 2021

Status verified date

Jul, 2021

Completion date

Jan, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Lung Cancer

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.

Interventions

Idylla EGFR Mutation Test

This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.

Primary outcome measure

  • Idylla EGFR Mutation Test [ Time Frame: Retrospective tissue samples no longer than 5 years old ]

Central Contacts and Locations

Central contacts

Hannah Park, BS

754-242-9682hannah.park@proteanbiodx.com

So Hyeon Park, MS

754-242-9682sohyeon.park@proteanbiodx.com

Locations

6555 Sanger Rd, Suite 260

Recruiting

Orlando, Florida, United States, 32827

Contacts

Hannah Park, BS

754-242-9682hannah.park@proteanbiodx.com

So Hyeon Park, MS

754-242-9682sohyeon.park@proteanbiodx.com

Principal Investigator:

Anthony Magliocco, MD

More Information

Sponsor

Anthony Magliocco

Last update posted

Jul 14, 2021

Last verified

Jul, 2021

Keywords

  • Protean BioDiagnostics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anthony Magliocco on 2021-07-14.