Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Primary Outcome
Study Overview
Brief Summary
The study aims to evaluate the Plasma-SeqSensei™ Solid Cancer IVD Kit NGS diagnostic test (Sysmex) before its introduction into routine diagnostics. This is a test for research of EGFR mutations in cfDNA that needs to be evaluated in a patient population with lung adenocarcinoma already characterized for EGFR mutations by a molecular test of reference. The proposed study does not present any risk to participants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or Females aged at least 18 years;
- •Patients with advanced or metastatic non-small cell lung cancer at diagnosis or progression who have previously had the cobas® EGFR Mutation Test v2 (Roche) performed on a liquid biopsy with a valid result (positive or negative);
- •Availability of 6 mL of plasma.
Exclusion Criteria
- •Plasma not available in sufficient quantities to perform both tests;
- •Cobas test with invalid result.
Arms & Interventions
SeqSensei™ Solid Cancer IVD Kit (Sysmex)
Intervention: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex) (Diagnostic Test)
cobas® EGFR Mutation Test v2 (Roche)
Intervention: cobas® EGFR Mutation Test v2 (Roche) (Diagnostic Test)
Outcomes
Primary Outcomes
Primary Outcome
Time Frame: Through study completion, an average of 1 year
Evaluate the capability of the NGS test Plasma-SeqSensei™ Solid Cancer IVD Kit (Sysmex) in detecting a greater number of EGFR mutations compared to the diagnostic test routine cobas® EGFR Mutation Test v2 (Roche)
Secondary Outcomes
- Secondary Outcome(Through study completion, an average of 1 year)