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New blood test could spot lung cancer mutations more accurately

NCT ID NCT06595498

Diagnosis Sponsor: Istituto Oncologico Veneto IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests a new, ultra-sensitive blood test (NGS) to detect EGFR gene mutations in patients with advanced lung cancer. Researchers will compare it to the current standard test using stored blood samples from 130 patients. The goal is to see if the new method finds more mutations, which could guide personalized treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Plasma-SeqSensei™ Solid Cancer IVD Kit (a blood test)
What this could lead to
If successful, this could provide a more sensitive blood test for lung cancer mutations, helping doctors choose better treatments without invasive biopsies.
What could go wrong
This is an early evaluation study, not a treatment trial. The new test may not prove more accurate than the current standard, and results may not change patient care immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

130 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

carcinoma lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung cancer (NSCLC)

Contacts and locations

Locations

  • Istituto Oncologico Veneto

    Padova, 35128, Italy

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