Status:
RECRUITING
Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
Lead Sponsor:
Istituto Oncologico Veneto IRCCS
Conditions:
Carcinoma, Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
NA
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 cf...
Eligibility Criteria
Inclusion
- 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
- Plasma not available in sufficient quantities to perform both tests;
- Cobas test with invalid result.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06595498
Start Date
July 1 2024
End Date
January 1 2026
Last Update
September 19 2025
Active Locations (1)
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1
Istituto Oncologico Veneto
Padua, Italy, 35128