Idylla EGFR Lung Trial
Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedJuly 14, 2021
July 1, 2021
1.3 years
December 17, 2020
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.
Eligibility Criteria
Target population is patients diagnosed with primary lung cancer and potentially have known EGFR mutation status.
You may qualify if:
- 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
You may not qualify if:
- Limited or no tissue available
- Only tissue available is from fine needle aspiration
- Tissue blocks older than 5 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
6555 Sanger Rd, Suite 260
Orlando, Florida, 32827, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Magliocco, MD
CEO and Founder
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 17, 2020
First Posted
July 14, 2021
Study Start
August 1, 2021
Primary Completion
December 1, 2022
Study Completion
January 1, 2023
Last Updated
July 14, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share