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Trial Title:
Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients with Lung Cancer
NCT ID:
NCT06595498
Condition:
Carcinoma, Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
lung cancer
non-small cell lung cancer
EGFR mutation
Next Generation Sequencing
plasma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Plasma- SeqSensei™ Solid Cancer IVD Kit (Sysmex)
Description:
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).
Arm group label:
SeqSensei™ Solid Cancer IVD Kit (Sysmex)
Intervention type:
Diagnostic Test
Intervention name:
cobas® EGFR Mutation Test v2 (Roche)
Description:
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).
Arm group label:
cobas® EGFR Mutation Test v2 (Roche)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Oncologico Veneto
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Indraccolo, Prof
Phone:
049 8215875
Email:
stefano.indraccolo@iov.veneto.it
Start date:
July 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Source:
Istituto Oncologico Veneto IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06595498
