NCT02500693|CompletedDMC
Circulating Tumor Cells in Lung Cancer Screening
AIR
Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease
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AIR
Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease
Sponsor study identifier
interventional
683
1 country
20
Study Start
October 30, 2015
Actual (reported)Primary Completion
October 13, 2020
Actual (reported)Study Completion
October 13, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 13, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2015
Actual (reported)July 16, 2015
Actual (reported)October 30, 2015
Actual (reported)October 13, 2020
Actual (reported)October 13, 2020
Actual (reported)Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
3 years
Rate of detection of CTC in the whole study population
once a year for 3 years
Circulating tumor cells
once a year for 3 years
Time span between detection of CTC and detection of lung cancer with LDCT and vice versa
once a year for 3 years
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU d'Amiens
Amiens, France
CHU de Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
CHRU de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
Hôpital Nord
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Nancy
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.
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.
Charles-Hugo MARQUETTE, Pr
Centre Hospitalier Universitaire de Nice
683 participants (actual enrollment reported by the registry).
First Submitted
July 15, 2015
First Posted
July 16, 2015
Study Start
October 30, 2015
Actual (reported)Contact the study team to confirm eligibility.
Nancy, France
Hôpital Bichat
Paris, France
Hôpital Cochin
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital TENON
Paris, France
CHU de Reims
Reims, France
CHU de Rennes
Rennes, France
CH de Roubaix
Roubaix, France
CHU de Rouen
Rouen, France
CHU de Saint Etienne
Saint-Etienne, France
CHU de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France
CHU de Tours
Tours, France
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.
Primary Completion
October 13, 2020
Actual (reported)Study Completion
October 13, 2020
Actual (reported)Last Updated
March 24, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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