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临床试验/NCT06933758
NCT06933758招募中不适用

Temple Health Chest Initiative (THCI 2.0) - Lung Cancer Screening Project With COPD Detection

Temple University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
COPD Prevalence

研究概览

简要总结

Chronic obstructive pulmonary disease is highly prevalent globally, with considerable morbidity and mortality associated. In the US, it is the 4th leading cause of death, as well as contributing to significant costs on healthcare utilization including hospitalization. Population-based screening for COPD has not been recommended by the US Preventative Services Task Force (USPSTF). However, LDCT screening for lung cancer in patients aged 50- 80 with ≥ 20 pack year smoking has been shown to improve survival. COPD is highly prevalent within LCS programs, with estimated rates of obstructive lung function of up to 59% and evidence of emphysema on CT scan in around 70%.

详细描述

The rates of undiagnosed COPD are reported to be between 20 to 40% 1, 2, 3 with all GOLD stages of disease identified. Of those with no known diagnosis, up to 50% had symptoms consistent with COPD1. Currently, population-based screening is not recommended for COPD by the US Preventive Services Task Force (USPSTF)4. However, given the overlapping risk factors for COPD and lung cancer, there are existing opportunities to target identification of COPD within a high-risk group and build further understanding of the impact on outcomes of earlier diagnosis, phenotyping of disease and implementation of treatment. Screening for early lung cancer using low dose CT imaging also affords the opportunity to explore presence of comorbidities on images, such as presence and extent of emphysema and other lung parenchymal and airway abnormalities and coronary artery calcification. There is also an opportunity to explore the role of imaging biomarkers for COPD such as LAA and airway inflammation, in determining risk of disease progression through longitudinal observation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 to 80 years old
  • Screened for early lung cancer using low dose CT imaging

排除标准

  • Under 50; over 80 years old
  • No lung cancer screening

结局指标

主要结局

COPD Prevalence

时间窗: 15 months

Determine COPD prevalence utilizing \< 0.7 FEV1/FVC plus evidence of emphysema by quantitated HRCT in the THCI lung cancer screening population.

次要结局

  • Severity of COPD(15 months)
  • Demographic Characteristics(15 months)
  • Incidence of Comorbid Lung and Non-lung Problems(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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