Circulating Tumor Cells in Lung Cancer Screening
AIR
Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
683
1 country
20
Brief 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). 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedStudy Start
First participant enrolled
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2020
CompletedMarch 24, 2026
March 1, 2026
5 years
July 15, 2015
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
3 years
Secondary Outcomes (3)
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
Study Arms (1)
Screening
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Age 55 years or more
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
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
Related Publications (3)
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.
PMID: 25360587BACKGROUNDMarquette 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.
PMID: 32649919RESULTLeroy 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.
PMID: 29282271DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles-Hugo MARQUETTE, Pr
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 16, 2015
Study Start
October 30, 2015
Primary Completion
October 13, 2020
Study Completion
October 13, 2020
Last Updated
March 24, 2026
Record last verified: 2026-03