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Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer

CompletedNA

Sponsor: Istituto Oncologico Veneto IRCCS

Conditions: Carcinoma, Non-small Cell Lung Cancer (NSCLC)

Interventions: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex), cobas® EGFR Mutation Test v2 (Roche)

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Padova, Italy