Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 683
- 试验地点
- 20
- 主要终点
- Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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].
结局指标
主要结局
Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
时间窗: 3 years
次要结局
- 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)
- Rate of detection of CTC in the whole study population(once a year for 3 years)