HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,100
- 试验地点
- 3
- 主要终点
- Primary endpoint
研究概览
简要总结
The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers.
详细描述
Germany has a long history of offering screening programs for cancers, such as breast, colorectal, and, more recently, cervical and skin cancer. Screening for lung cancer, however, which causes more deaths than any other cancer in men and is the second leading cancer death in women (not far behind breast cancer), has not been implemented to date. Only very recently, Institute for Quality and Efficiency in Healthcare (IQWiG) in a preliminary assessment of low-dose CT screening, concluded that the benefits from screening outweigh potential risks. However, an implementation of a national lung cancer screening program, which would be covered by the general health insurance, will likely not be implemented before 2022.
Nonetheless, the IQWiG report also comments on important criteria for implementing lung cancer screening in Germany using low-dose CT:
- It would be necessary to determine criteria that define a high-risk population. Various risk forecasting models are currently being propagated to enable a more precise selection of high-risk individuals. Their reliability and repeatability needs to be checked.
- Integration of access to a smoking cessation program.
- Quality assurance measures must be taken into account, including standardized protocols for the evaluation of the CT images and the subsequent follow-up checks as well as the invasive diagnostic tissue sampling procedures. The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
Randomized reporting of coronary calcium score and emphysema score
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 55-79 years
- •Current or former smokers
- •Subjects with calculated risk score PLCOM2012 ≥1.58% (6 yrs.) or NELSON inclusion criteria (current or former smokers [those who had quit ≤10 years ago] who had smoked >15 cigarettes a day for >25 years or >10 cigarettes a day for >30 years).
- •Able and willing to give written informed consent In addition, non-qualifying subjects fulfilling inclusion criteria 1 (age), 2 (smoking history) and 4 (consent), but do not meet the inclusion criterion 3 (risk too low) will be asked to volunteer by contributing long-term outcome data informing of the development of lung cancer or death from lung cancer (about n=7100 randomly selected from all 3 centers, low-risk group). These subjects will be contacted via mail after a minimum of 5 year follow up to inquire if they developed lung cancer in the time between their recruitment and present. Non-responders will be followed by local registries and by phone. New lung cancer cases will be verified using official hospital or cancer registry documents.
排除标准
- •Comorbidity, which would unequivocally contraindicate either screening or treatment if lung cancer is detected.
- •History of chest CT within the past year preceding the invitation.
- •Inability to undergo non-contrast CT (e.g. ≥ 200 kg body weight, inability to lie flat).
- •Risk of non-compliance with study procedures.
- •Unable to give written consent
- •Patient's inability to fill in the questionnaire self-dependent
- •Limited knowledge of the German language
- •Inability to travel, residents of care facilities, etc.
研究组 & 干预措施
Reporting group (coronary calcium score and emphysema score)
Coronary calcium score and emphysema score are reported to subjects
干预措施: Low-dose CT screening (Radiation)
Reporting group (coronary calcium score only)
Only coronary calcium score is reported to subjects
干预措施: Low-dose CT screening (Radiation)
Reporting group (emphysema score only)
Only emphysema score is reported to subjects
干预措施: Low-dose CT screening (Radiation)
Non-reporting group
Coronary calcium score and emphysema score are not reported to subjects
干预措施: Low-dose CT screening (Radiation)
Low-risk group
No CT screening, collection of health data only
结局指标
主要结局
Primary endpoint
时间窗: 5 years
Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds.
次要结局
- Key secondary endpoint 1(1 year)
- Key secondary endpoint 2(5 years)
- Key secondary endpoint 3(5 years)
- Key secondary endpoint 4(5 years)
- Key secondary endpoint 5(5 years)
- Additional secondary endpoint 1(1 year)
- Additional secondary endpoint 2(1 year)
- Additional secondary endpoint 3.1(1 year)
- Additional secondary endpoint 3.2(1 year)
- Additional secondary endpoint 3.3(1 year)
- Additional secondary endpoint 3.4(1 year)
- Additional secondary endpoint 4.1(1 year)
- Additional secondary endpoint 4.2(1 year)
- Additional secondary endpoint 4.3(1 year)
- Additional secondary endpoint 4.4(1 year)
- Additional secondary endpoint 5(1 year)
- Additional secondary endpoint 6.1(1 year)
- Additional secondary endpoint 6.2(1 year)
- Additional secondary endpoint 7.1(1 year)
- Additional secondary endpoint 7.2(1 year)