Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Assessment of change of the number of patients diagnosed by LDCT
研究概览
简要总结
Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus), nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and some myeloid leukemias.
This study aims to evaluate the combined effect of the scanner and the search for circulating tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers to cessation and addressing the psychological impact this approach.
详细描述
Study Objectives:
The study takes two lines of research:
1 - Imaging and Research circulating tumor cells:
The main objective is to evaluate the diagnostic value of the couple scanner low intensity and speed search of circulating tumor cells (CTC-LDCT) for screening in a population at high risk of lung cancer.
The secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with at least a cumulative smoking 30 pack-years,
- •Active or weaned smoking since less than 15 years,
- •Who consults or is hospitalized in a medical services or vascular surgery 'Paris Saint Joseph Hospital Group' (GHPSJ) or 'the European Hospital Georges Pompidou' (HEGP) for occlusive arterial disease or aneurysm the abdominal aorta,
- •Accepting the repeat CT scans and blood tests, as provided for by the protocol and additional investigations which might be necessitated by the detection of abnormality (s) to previous reviews,
- •Accepting, in case of continuing active smoking, engage in smoking cessation process.
排除标准
- •Bronchial history of cancer,
- •Diagnosis and / or previous treatment of another cancer within 5 years prior to study entry, with the exception of skin tumors and non melanomatous carcinoma in situ,
- •Anterior resection pulmonary parenchyma, severe respiratory failure against-indicating any invasive procedure on the lung,
- •Signs of presence and / or symptoms that may be due to a pre-existing cancer (eg, unexplained weight loss of more than 10% of initial body weight over the last 12 months, hemoptysis, ...)
- •ECOG activity index ≥ 2,
- •Acute respiratory infection that led to antibiotic therapy within 12 weeks prior to study entry,
- •Renal impairment does not authorize, where appropriate, a contrast agent injection,
- •Comorbidity (s) may increase the risk of death during the course of the trial.
结局指标
主要结局
Assessment of change of the number of patients diagnosed by LDCT
时间窗: Day 1, Month 6, Month 12
number of patients diagnosed by LDCT (Low Dose CT-scanner)
Assessment change of the number of patients diagnosed with CTC identification
时间窗: Day 1, Month 6, Month 12
Number of patients diagnosed with CTC (Circulating Tumor Cells) identification
次要结局
- Assessment of the psychologic impact of screening a cancer(Day 1,)