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

Not Applicable

Recruiting

• Conditions: Carcinoma, Non-small Cell Lung Cancer (NSCLC)
• Interventions: Diagnostic Test: Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex); Diagnostic Test: cobas® EGFR Mutation Test v2 (Roche)

• Registration Number: NCT06595498
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-08-07
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SeqSensei™ Solid Cancer IVD Kit (Sysmex)	Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex)	-
cobas® EGFR Mutation Test v2 (Roche)	cobas® EGFR Mutation Test v2 (Roche)	-

Primary Outcome Measures

Name	Time	Method
Primary Outcome	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 Outcome Measures

Name	Time	Method
Secondary Outcome	Through study completion, an average of 1 year	Check if the NGS Plasma-SeqSensei™ Solid Cancer IVD Kit (Sysmex) is comparable to conventional test (cobas® EGFR MutationTest v2 (Roche)) in the detection of the mutational status of EGFR

Trial Locations

Locations (1)

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy