Circulating Tumor Cells in Lung Cancer Screening (AIR)

March 20, 2026 updated by: Centre Hospitalier Universitaire de Nice

Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease

This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination with unenhanced (without injection of contrast media) low dose (to limit the effective radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung cancer (LC).

LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55 years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of false positive that require repeat follow-up and also invasive investigations, but also false negatives with metastatic LC being discovered between screening rounds.

Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on LDCT.

The study will focus on patients at very high risk for lung cancer i.e. smokers and ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).

The study will enroll 600 participants who will undergo three rounds of screening at one year intervals, each round combining search for CTC on a blood sample and LDCT. Each participant will be followed for at least one year after the last screening round

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU d'AMIENS
      • Dijon, France
        • Chu de Dijon
      • Grenoble, France
        • CHU de Grenoble
      • Lille, France
        • CHRU de Lille
      • Lyon, France
        • Hospices Civils de Lyon
      • Marseille, France
        • Hopital Nord
      • Montpellier, France
        • CHU de Montpellier
      • Nancy, France
        • CHU de Nancy
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Hopital Cochin
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hôpital Tenon
      • Reims, France
        • Chu de Reims
      • Rennes, France
        • CHU de Rennes
      • Roubaix, France
        • CH de Roubaix
      • Rouen, France
        • CHU de Rouen
      • Saint-Etienne, France
        • CHU de Saint Etienne
      • Strasbourg, France
        • CHU de Strasbourg
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 55 years or more
  • 30 or more pack-years of cigarette smoking history
  • Former smokers: quit smoking within the previous 15 years
  • Signed informed consent form
  • Presence of COPD
  • Affiliation to the French social security system

Exclusion Criteria:

  • Chest CT examination in the 12 months prior to eligibility assessment(1)
  • Treatment for, or evidence of, any cancer other than skin basocellular carcinoma in the 5 years prior to eligibility assessment
  • Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment
  • Unexplained weight loss of more than 15 10%pounds in the 12 months prior to eligibility assessment
  • Recent hemoptysis
  • History of lung volume reduction with coils, glue or valves°
  • Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods
  • Participation in another cancer screening trial
  • Participation in a cancer prevention study, other than a smoking cessation study
  • Vulnerable persons: adults under guardianship, adults under trusteeship 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

    1. Many COPD patients will have had a previous chest CT examination. This has become common in medical practice, especially in patients with chronic lung diseases such as COPD patients. Including such patients would introduce huge bias in the study by artificially focusing on rapidly growing cancers. Redoing a CT in a screening intend in a patient who recently underwent this investigation would also unnecessarily enhance irradiation in these patients. It should be note that in the NLST trial "previous chest CT (≤ 18 months)" was a key exclusion criterion [NLST Radiology 2011].

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening
Biological: Isolation of circulating tumor cells (CTC) from veinous blood
Thirty ml of peripheral blood will be collected in buffered EDTA, maintained at 4°C, and processed within 1 hour for filtration. After blood filtration, the membrane will be gently washed with PBS, disassembled from the filtration module, and allowed to air-dry. The determination of CTC number present on filters will be carried out by combining four color immunofluorescent (anti-pancytokeratins/anti-vimentin/DAPI/anti-CD45) staining and cytomorphological examination after Diff-quick and Mayer Hemalun staining in three spots per patient sample. Imaging of immunofluorescent and cytological staining will be performed at x20 magnification using the automated Ariol system. CTCs are identified by relocating images of immunofluorescent and cytological staining.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of detection of CTC in the whole study population
Time Frame: once a year for 3 years
once a year for 3 years
Circulating tumor cells
Time Frame: once a year for 3 years
Predictive value of CTC detection for the diagnosis of LC in patients identified as having a pulmonary nodule.
once a year for 3 years
Time span between detection of CTC and detection of lung cancer with LDCT and vice versa
Time Frame: once a year for 3 years
once a year for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Charles-Hugo MARQUETTE, Pr, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2015

Primary Completion (Actual)

October 13, 2020

Study Completion (Actual)

October 13, 2020

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimated)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-PP-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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