Testing a new method to detect EGFR gene mutations in lung cancer patients' blood
Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients with Lung Cancer
NA · Istituto Oncologico Veneto IRCCS · NCT06595498
This study is testing a new blood test to see if it can better detect EGFR gene mutations in people with non-small cell lung cancer compared to current methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Oncologico Veneto IRCCS (other) |
| Locations | 1 site (Padova) |
| Trial ID | NCT06595498 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Plasma-SeqSensei™ Solid Cancer IVD Kit, a next-generation sequencing diagnostic test designed to detect EGFR mutations in the plasma of patients with non-small cell lung cancer (NSCLC). Participants must have previously undergone a cobas® EGFR Mutation Test v2 and provide a plasma sample for analysis. The goal is to assess the effectiveness of this new method compared to established testing protocols, with no risk to participants involved. The study aims to enhance diagnostic accuracy for lung cancer treatment planning.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic non-small cell lung cancer who have previously had a valid cobas® EGFR Mutation Test v2 result.
Not a fit: Patients without sufficient plasma samples or those with invalid results from the cobas test may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection of EGFR mutations in lung cancer patients, leading to more personalized and effective treatment options.
How similar studies have performed: Other studies have shown promise in using next-generation sequencing for similar diagnostic purposes, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Padova
- Istituto Oncologico Veneto — Padova, Italy (RECRUITING)
Study contacts
- Study coordinator: Stefano Indraccolo, Prof
- Email: stefano.indraccolo@iov.veneto.it
- Phone: 049 8215875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carcinoma, Non-small Cell Lung Cancer, lung cancer, non-small cell lung cancer, EGFR mutation, Next Generation Sequencing, plasma