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Brief Title: Circulating Tumor Cells in Lung Cancer Screening
Official Title: Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease
Study ID: NCT02500693
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
Detailed Description:
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Charles-Hugo MARQUETTE, Pr
Affiliation: Centre Hospitalier Universitaire de Nice
Role: PRINCIPAL_INVESTIGATOR