Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
Status: Active_not_recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
Istituto Oncologico Veneto
Padova
Time Frame
Start Date: 2024-07-01
Completion Date: 2026-06-30
Participants
Target number of participants: 130
Treatments
Experimental: SeqSensei™ Solid Cancer IVD Kit (Sysmex)
Active_comparator: cobas® EGFR Mutation Test v2 (Roche)
Related Therapeutic Areas
Sponsors
Leads: Istituto Oncologico Veneto IRCCS