NCT06595498Completed
Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients With Lung Cancer
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 7 Aug 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 22 Dec 2025
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Diseases
- Lung cancer
- NCT number
- NCT06595498
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 1 Jul 2024 to the primary completion date, 22 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Plasma not available in sufficient quantities to perform both tests;
- Cobas test with invalid result.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.