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临床试验/NCT06537804
NCT06537804进行中(未招募)不适用

Project Lung Cancer Screening in Southern Denmark

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 1,332 人开始时间: 2024年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,332
试验地点
2
主要终点
Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold

研究概览

简要总结

One thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. The participants will be identified through an initial questionnaire survey concerning smoking history and general health. Project participants are offered a low-dose CT (LDCT) scan annually for three consecutive years. In relation to the first scan, a lung function test will also be performed. The screening process will be evaluated for possible national implementation of a lung cancer screening program in Denmark.

详细描述

This pilot study is a prospective interventional feasibility study. The primary goal is to evaluate the impact on healthcare organization, administration of resources and costs, and thereby assessing the feasibility of implementing systematic screening for lung cancer among people at high risk in Denmark (current or former heavy smokers). The pilot study will be performed on Funen in the Region of Southern Denmark and will run over three years (2024-2026). One thousand randomly selected participants aged 60-74 years old, who meet the screening criteria, will receive annual LDCT scans for three consecutive years.

Data will be collected continuously throughout the study period. The analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. Furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). The analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. Finally, the radiologists' assessments of the project's LDCT scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.

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
None

入排标准

年龄范围
60 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Heavy smokers (≥ 30 pack years) or citizens with a PLCOm2012 calculated 6-year risk of lung cancer > 2%.
  • •Age: 60-74 years old
  • •Residence on Funen and surrounding islands

排除标准

  • •Cancer treatment or follow-up (except non melanoma skin cancer and similar low malignant cancers) within the past 12 months
  • •CT scan performed within the past 12 months

研究组 & 干预措施

Intervention

Other

Low-dose CT scans are performed once a year from 2024 to 2026 to screen for lung cancer including a lung function test the first year of attendance (2024).

干预措施: Screening by low-dose CT scan (Radiation)

Control

No Intervention

Citizens from the cohort who are randomized to no intervention.

结局指标

主要结局

Lung cancer screening cost-effectiveness analysis quantified in the form of incremental cost-effectiveness ratio threshold

时间窗: Up to 36 months

ratio

次要结局

  • Characteristics of citizens from the cohort based on registry data(Up to 36 months)
  • Participation rate(36 months (complete study period))
  • Dropouts(36 months (complete study period))
  • Lung cancer found on low dose CT-scans(Baseline, after 1 year, after 2 years)
  • FEV1(Baseline)
  • Smoking history(baseline)
  • Inconclusive or non-malignant findings on low dose CT scans(Baseline, after 1 year, after 2 years)
  • FVC(Baseline)
  • Hospitalization time(36 months (complete study period))
  • Self-reported smoking status(Baseline, after 1 year, after 2 years)
  • Weight(Baseline)
  • All-cause-mortality(36 months (the entire study period))
  • Treatment diagnose - any other disease (found on low dose CT scans)(36 months (complete study period))
  • Referral to follow-up procedures(36 months Entire study period)
  • Self reported health and quality of life assessed by the EQ-5D-5L questionnair(Baseline and after 2 years)
  • Gender(Baseline)
  • Treatment diagnose - cancer(36 months (complete study period))
  • Height(Baseline)
  • Total time consumption of extra work at involved departments: department of lung diseases, department of radiology and department og pulmonary diseases(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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