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Blood test may replace painful lung biopsies for some cancer patients

NCT ID NCT02372448

Diagnosis Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a blood test can detect ALK gene rearrangements in lung cancer patients, which currently requires an invasive tumor biopsy. Researchers analyzed circulating tumor cells from blood samples of 206 patients with advanced lung cancer. The goal was to see if this 'liquid biopsy' is accurate enough to guide treatment decisions, potentially avoiding the risks and costs of traditional biopsies.

What this could mean

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

Active substance
ALK analysis on circulating tumor cells detected by ISET method
What this could lead to
If successful, this blood test could replace invasive lung biopsies for detecting ALK gene changes, helping more lung cancer patients get targeted therapy without risky procedures.
What could go wrong
This is a validation study, not a treatment trial. The test may not be sensitive enough to replace biopsies, and results may not apply to all lung cancer types or stages.

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

206 people

The number who actually took part.

Started

Jan 2015

Finished

Nov 2019

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: * Age 18 years old or older * Histologically confirmed stage IIIb/IV non-squamous NSCLC undergoing biopsy or surgery * Presence of ALK rearrangement result by FISH analysis (gold standard method) on tumor tissue * Signed specific informed consent approved by the Institutional Review Board prior to patient entry * Affiliation to the social security system Exclusion Criteria: * Vulnerable persons: adults under guardianship or persons deprived of their liberty, patients under 18 years old * Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Lung neoplasms

Contacts and locations

Locations

  • CHU de Nice

    Nice, France

  • Centre Antoine Lacassagne

    Nice, 06100, France

  • Centre François Baclesse

    Caen, 14000, France

  • Grenoble university hospital

    Grenoble, 38043, France

  • Hôpital Tenon

    Paris, 75020, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut arnault tzanck

    Saint-Laurent-du-Var, 06700, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54500, France

  • Marseille University Hospital

    Marseille, 13915, France

  • Nancy university hospital

    Nancy, 54511, France

  • Toulouse University Hospital

    Toulouse, 31059, France

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