Circulating Tumor Cells in Lung Cancer Screening (AIR)
|ClinicalTrials.gov Identifier: NCT02500693|
Recruitment Status : Unknown
Verified January 2018 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : January 9, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Pulmonary Disease, Chronic Obstructive||Biological: Isolation of circulating tumor cells (CTC) from veinous blood||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease|
|Actual Study Start Date :||October 30, 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Biological: Isolation of circulating tumor cells (CTC) from veinous blood
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.
- Rate of detection of circulating tumor cells in patients who will have a LC detected during the study [ Time Frame: 3 years ]
- Rate of detection of CTC in the whole study population [ Time Frame: once a year for 3 years ]
- Circulating tumor cells [ Time Frame: once a year for 3 years ]Predictive value of CTC detection for the diagnosis of LC in patients identified as having a pulmonary nodule.
- Time span between detection of CTC and detection of lung cancer with LDCT and vice versa [ Time Frame: once a year for 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500693
|Principal Investigator:||Charles-Hugo MARQUETTE, Pr||Centre Hospitalier Universitaire de Nice|