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

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.

NCT Number	NCT06595498
Lead Sponsor	Istituto Oncologico Veneto IRCCS
Conditions	Carcinoma, Non-small Cell Lung Cancer (NSCLC)
Enrollment	130 participants
Start Date	2024-07-01
Primary Completion	2025-12-22 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-04