Circulating Tumor Cells in Lung Cancer Screening (AIR)

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Lung Neoplasms

Pulmonary Disease, Chronic Obstructive

Treatments

Biological: Isolation of circulating tumor cells (CTC) from veinous blood

Study type

Interventional

Funder types

Other

Identifiers

NCT02500693

15-PP-08

Details and patient eligibility

About

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

Enrollment

683 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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].