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

Istituto Oncologico Veneto IRCCS

Status: Enrolling

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

Treatments: Diagnostic Test: cobas® EGFR Mutation Test v2 (Roche); Diagnostic Test: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex)

Study type: Interventional

Funder types: Other

Identifiers

NCT06595498

RARE study

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

SeqSensei™ Solid Cancer IVD Kit (Sysmex)

Experimental group

Treatment:

Diagnostic Test: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex)

cobas® EGFR Mutation Test v2 (Roche)

Active Comparator group

Treatment:

Diagnostic Test: cobas® EGFR Mutation Test v2 (Roche)