An observational study in Lung Cancer, Technology and Oncology, sponsored by Anthony Magliocco. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Anthony Magliocco · Observational
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 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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 150 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Anthony Magliocco is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Target population is patients diagnosed with primary lung cancer and potentially have known EGFR mutation status.
Exclusion Criteria:
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
This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.
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.
Time frame: Retrospective tissue samples no longer than 5 years old
Plan to share: No
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Anthony Magliocco