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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.
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 Idyllaâ„¢ EGFR Mutation Test, performed on the BioCartis Idyllaâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idylla EGFR Mutation Test | Diagnostic Test | This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Target population is patients diagnosed with primary lung cancer and potentially have known EGFR mutation status.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Park, BS | Contact | 754-242-9682 | hannah.park@proteanbiodx.com | |
| So Hyeon Park, MS | Contact | 754-242-9682 | sohyeon.park@proteanbiodx.com |
| Name | Affiliation | Role |
|---|---|---|
| Anthony Magliocco, MD | CEO and Founder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 6555 Sanger Rd, Suite 260 | Recruiting | Orlando | Florida | 32827 | United States |
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| Label | URL |
|---|---|
| Company Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| D012140 |
| Respiratory Tract Diseases |