Lung CancerNCT04962191
Idylla EGFR Lung Trial
An observational study of Lung Cancer and Technology, run by Anthony Magliocco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Technology, Oncology
- What is being tested?
- Idylla EGFR Mutation Test
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2021to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Target population is patients diagnosed with primary lung cancer and potentially have known EGFR mutation status.
Who may be able to join
- 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
Who cannot join
- Limited or no tissue available
- Only tissue available is from fine needle aspiration
- Tissue blocks older than 5 years old
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
6555 Sanger Rd, Suite 260
Orlando, Florida, 32827
Hannah Park, BS, 754-242-9682, hannah.park@proteanbiodx.com
So Hyeon Park, MS, 754-242-9682, sohyeon.park@proteanbiodx.com
About this study
Official title: Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care
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.
Read the detailed 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.
- Conditions
- Lung Cancer, Technology, Oncology
- Being tested
- Idylla EGFR Mutation Test
- Keywords
- Protean BioDiagnostics
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idylla EGFR Mutation TestDiagnostic test
This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Idylla EGFR Mutation Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective tissue samples no longer than 5 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthony Magliocco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Anthony Magliocco, Protean BioDiagnostics
- Investigators
- Anthony Magliocco, MD, Principal investigator, CEO and Founder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962191
- Sponsor's protocol ID
- R20-00012
- Status last verified
- Jul 2021
- First submitted
- 17 Dec 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Study: Measuring Potential Impact of Research Use Only Rapid EGFR Testing on Standard of Care
- ClinicalTrials.gov ID
- NCT04962191
- Acronym / sponsor ID
- R20-00012
- Conditions
- Lung Cancer, Technology, Oncology
- Keywords
- Protean BioDiagnostics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anthony MaglioccoIndustry (pharma, biotech, devices)
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer | – | Diagnostic Test: Idylla EGFR Mutation TestThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population is patients diagnosed with primary lung cancer and potentially have known EGFR mutation status.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Limited or no tissue available
- Only tissue available is from fine needle aspiration
- Tissue blocks older than 5 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idylla EGFR Mutation TestThis diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations. | Diagnostic test | Lung Cancer |
Primary outcome
Idylla EGFR Mutation Test
Time frame: Retrospective tissue samples no longer than 5 years old
The primary outcome measured is if the Idylla EGFR Mutation Test is a possible alternative to diagnose EGFR mutation status in tissue samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Magliocco, MD principal investigator
CEO and Founder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Technology, run by Anthony Magliocco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Park, BS (754-242-9682, hannah.park@proteanbiodx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Idylla EGFR Mutation Test (time frame: Retrospective tissue samples no longer than 5 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021; AzTrials last refreshed its copy on 29 Oct 2026.