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

NCT06595498 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-small Cell Lung Cancer (NSCLC)

Interventions

DIAGNOSTIC_TEST

Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex)

The patients' blood has already been collected in Streck tubes for circulating DNA and the plasma has been stored at -80°C as per the procedure for the routine diagnostic test cobas EGFR Mutation Test v2. No further blood sampling will be required from patients. Circulating DNA/RNA will be extracted from 2-5 ml of plasma. The extracted cfDNA will be quantified. The libraries will be prepared using the NGS Plasma-SeqSensei™ Solid Cancer IVD Kit (Sysmex) and will be evaluated at the Tapestation (Agilent) to verify their quality and quantity using D1000 Screentapes. The libraries consisting of approximately 16 samples each will then be sequenced on an Illumina NextSeq 500 sequencer using the Illumina NextSeq 500/550 Mid Output Kit v2.5 (150 Cycles). Data analysis will be performed using Plasma-SeqSensei™ IVD Software (Sysmex).

DIAGNOSTIC_TEST

cobas® EGFR Mutation Test v2 (Roche)

The patients' blood has already been collected in Streck tubes for circulating DNA and the plasma has been stored at -80°C as per the procedure for the routine diagnostic test cobas EGFR Mutation Test v2. No further blood sampling will be required from patients. Circulating DNA/RNA will be extracted from 2-5 ml of plasma. The extracted cfDNA will be quantified. The libraries will be prepared using the cobas® EGFR Mutation Test v2 (Roche) and will be evaluated at the Tapestation (Agilent) to verify their quality and quantity using D1000 Screentapes. The libraries consisting of approximately 16 samples each will then be sequenced on an Illumina NextSeq 500 sequencer using the Illumina NextSeq 500/550 Mid Output Kit v2.5 (150 Cycles).

Sponsors & Collaborators

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-22
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06595498 on ClinicalTrials.gov