Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- number of complete phenotyping clinical, clinical
研究概览
简要总结
Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer > 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile
Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45- 75 years and
- •Medical follow-up for a smoking-related pathology :
- •chronic obstructive pulmonary disease / emphysema
- •history of non evolving cancer > 5 years among: ENT, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia,
- •daily smoking for at least 10 years prior to the disease Or
- •NLST inclusion criteria:
- •Age 55 - 74 years
- •Cumulative smoking ≥ 30 pack-years
- •active or quit for less than 15 years Or
- •Inclusion criterion in NELSON:
- •Age 50-75 years
- •> 15 cigarettes/D for more than 25 years or
- •> 10 cigarettes /D for more than 30 years
- •Active smoking or cessation < 10 years Or
- •New American recommendations :
- •Age 50 - 80 years
- •Smoking ≥20 PA
- •Active or weaned <15 years
排除标准
- •history of cancer < 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable PSA)
- •Symptoms of lung cancer (unintentional weight loss > 7 kg in 1 year, hemoptysis)
- •known history of pulmonary nodule with specialized follow-up
- •history of pulmonary fibrosis or pulmonary hypertension
- •patient under guardianship or curatorship
- •active pulmonary parenchymal infection
- •severe cardiac or respiratory insufficiency (rest dyspnea)
- •patient not affiliated to the social security system (beneficiary or beneficiary's right)
- •Patient deprived of liberty
- •Performance status (WHO) 2, 3 or 4
- •Pregnant or breastfeeding women
研究组 & 干预措施
patients
干预措施: thoracic scan Low dose (Device)
patients
干预措施: BLOOD SAMPLE (Biological)
patients
干预措施: FECES SAMPLE (Biological)
结局指标
主要结局
number of complete phenotyping clinical, clinical
时间窗: 18 months
number of complete phenotyping biological samples
时间窗: 18 months
number of complete phenotyping radiological
时间窗: 18 months
次要结局
- Number of lung cancers diagnosed / Number of patients included(18 MONTHS)
- Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed(18 MONTHS)
- Satisfaction assessment(2 times (inclusion, 8 months))
- Number of oncological events (other than lung cancer) / number of patients included(18 months)
- Number of patients in partial smoking cessation / number of active smoking patients included(18 MONTHS)
- Assessment of ANXIETY(2 times (inclusion, 8 months))
- Number of initial positive scans / number of initial scans(18 months)
- Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures(18 months)
- Number of cardiovascular events / number of patients included(18 months)