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Lung NeoplasmsAIRNCT02500693

Circulating Tumor Cells in Lung Cancer Screening

A study testing Isolation of circulating tumor cells (CTC) from veinous blood in people with Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Universitaire de Nice at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Isolation of circulating tumor cells (CTC) from veinous blood
Could I receive a placebo?
No, everyone receives an active treatment
How many people
683 participants
Where
20 sitesFrance
Study dates
30 Oct 2015to 13 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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°
Show all 12Show fewer
  • 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
  • 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].

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • CHU d'Amiens

    Amiens

  • CHU de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • CHRU de Lille

    Lille

  • Hospices Civils de Lyon

    Lyon

  • Hôpital Nord

    Marseille

  • CHU de Montpellier

    Montpellier

  • CHU de Nancy

    Nancy

  • Hôpital Bichat

    Paris

  • Hôpital Cochin

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital TENON

    Paris

  • CHU de Reims

    Reims

  • CHU de Rennes

    Rennes

  • CH de Roubaix

    Roubaix

  • CHU de Rouen

    Rouen

  • CHU de Saint Etienne

    Saint-Etienne

  • CHU de Strasbourg

    Strasbourg

  • CHU de Toulouse

    Toulouse

  • CHU de Tours

    Tours

Other trials in France

About this study

Official title: 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.

Read more

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

Being tested
Isolation of circulating tumor cells (CTC) from veinous blood
Keywords
Lung Cancer, Screening, COPD
Medical subject headings
Lung Neoplasms, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isolation of circulating tumor cells (CTC) from veinous bloodBiological

    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.

Study groups in NCT02500693
Study groupRoleWhat they receive
ScreeningExperimentalNot described
Receives: Biological: Isolation of circulating tumor cells (CTC) from veinous blood

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of detection of circulating tumor cells in patients who will have a LC detected during the study

    Measured: 3 years

Secondary outcomes (3)

  1. Rate of detection of CTC in the whole study population

    Measured: once a year for 3 years

  2. Circulating tumor cells

    Predictive value of CTC detection for the diagnosis of LC in patients identified as having a pulmonary nodule.

    Measured: once a year for 3 years

  3. Time span between detection of CTC and detection of lung cancer with LDCT and vice versa

    Measured: once a year for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study start30 Oct 2015
  3. Primary completion13 Oct 2020
  4. Study completion13 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02500693
Sponsor's protocol ID
15-PP-08
Acronym
AIR
Status last verified
Mar 2026
First submitted
15 Jul 2015
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ilie M, Hofman V, Long-Mira E, Selva E, Vignaud JM, Padovani B, Mouroux J, Marquette CH, Hofman P. "Sentinel" circulating tumor cells allow early diagnosis of lung cancer in patients with chronic obstructive pulmonary disease. PLoS One. 2014 Oct 31;9(10):e111597. doi: 10.1371/journal.pone.0111597. eCollection 2014.

    PubMed 25360587

  • Marquette CH, Boutros J, Benzaquen J, Ferreira M, Pastre J, Pison C, Padovani B, Bettayeb F, Fallet V, Guibert N, Basille D, Ilie M, Hofman V, Hofman P; AIR project Study Group. Circulating tumour cells as a potential biomarker for lung cancer screening: a prospective cohort study. Lancet Respir Med. 2020 Jul;8(7):709-716. doi: 10.1016/S2213-2600(20)30081-3.

    PubMed 32649919

  • Leroy S, Benzaquen J, Mazzetta A, Marchand-Adam S, Padovani B, Israel-Biet D, Pison C, Chanez P, Cadranel J, Mazieres J, Jounieaux V, Cohen C, Hofman V, Ilie M, Hofman P, Marquette CH; AIR Project Study Group. Circulating tumour cells as a potential screening tool for lung cancer (the AIR study): protocol of a prospective multicentre cohort study in France. BMJ Open. 2017 Dec 26;7(12):e018884. doi: 10.1136/bmjopen-2017-018884.

    PubMed 29282271

Questions about this trial

What is this clinical trial studying?

A study testing Isolation of circulating tumor cells (CTC) from veinous blood in people with Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Centre Hospitalier Universitaire de Nice at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of detection of circulating tumor cells in patients who will have a LC detected during the study (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02500693, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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