Clinical trial · Interventional
Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-small Cell Lung Cancer (NSCLC) | Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cobas® EGFR Mutation Test v2 (Roche) | Diagnostic Test | — | UNRESOLVED |
| Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SeqSensei™ Solid Cancer IVD Kit (Sysmex)
- interventionNames
- Diagnostic Test: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex)
- type
- ACTIVE_COMPARATOR
- label
- cobas® EGFR Mutation Test v2 (Roche)
- interventionNames
- Diagnostic Test: cobas® EGFR Mutation Test v2 (Roche)
Primary outcomes (1)
- measure
- Primary Outcome
- timeFrame
- Through study completion, an average of 1 year
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available