Lung Cancer Screening by Low Dose CT Scan in a French Department (DEP KP80)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,307
- 试验地点
- 2
- 主要终点
- feasibility of lung cancer screening implementation in France: participation rate
研究概览
简要总结
Lung cancer is the leading cause of cancer death worldwide. The aims of this study were to assess the feasibility and effectiveness of a lung cancer screening pilot program with LD CT scan in a French department (Somme).
DEP KP80 was a single-arm, prospective study started in May 2016. The inclusion criteria were those of the National Lung Screening Trial. An annual LD CT scan was scheduled and 2 rounds were planned. Smoking cessation was encouraged as part of the protocol.
Subjects were selected by General Practitioner or Pneumologist who checked the inclusion criteria and prescribed the CT scan.
详细描述
Scientific context :
Lung cancer is the deadliest cancer in France and in the world. With around 39500 new cases in 2012 in France, lung cancer ranks fourth regarding cancer incidence for both women and men. In 2012 it caused the highest number of annual deaths linked to cancer (around 30 000 deaths) according to the Institut National Du Cancer (INCA). It is a real public health issue, its incidence has been increasing above all in women and its prognosis is grim. The 1-year survival rate is 43% and 5-year survival rate 14% whatever the stage of the disease.
The Picardy region presents an excess mortality of 18% compared to the national average for the lung cancer and Somme has one of the highest incidence rate in France for this cancer.
Research hypothesis:
If the investigators know that tobacco smoke is the main risk factor, the other feature of this cancer is characterized by a diagnosis at an advanced stage when only limited, palliative treatments which are heavy, and costly can be provided Proposing the screening test with low dose helical computed tomography (LD-CT) has the aim to spot this cancer at an early stage when a curative surgical treatment is still possible in order to improve the survival chances.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •smokers or former smoker,
- •aged between 55 and 74
- •tobacco exposure of more than 30 pack-years,
- •active smokers or who quitted for less than 15 years,
- •obvious symptoms.
排除标准
- •history of cancer within the last 5 years other than non melanoma skin cancer or carcinoma in situ,
- •worsening of their health state with Eastern Cooperative Oncology Group performance status>3,-
- •heart or respiratory severe co-morbidity with contraindications to thoracoscopy
研究组 & 干预措施
screening
participants performed lung cancer screening by Low Dose CT scan
干预措施: Low dose CT scan (Other)
结局指标
主要结局
feasibility of lung cancer screening implementation in France: participation rate
时间窗: 3 years
number of participants, participation rate : number of LD CT scan performed/ number of participants
efficacity of lung cancer screening in France: number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive
时间窗: 3 years
number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive
次要结局
未报告次要终点
研究者
Olivier LELEU
Head of pneumology department
Centre Hospitalier d'Abbeville