Temple Health Chest Initiative (THCI 2.0)

Официальное название

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

Обзор

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%.

Подробное описание

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.

Вмешательства

• Диагностический тест Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio
  Demonstrate utility of LDCT in COPD characterization Determine exacerbation risk and symptom burden in this patient population Determine the severity of COPD identified through this process Describe phenotypic characteristics including imaging analysis of THCI population Determine the suitability and acceptance of patients to participate in COPD clinical trials Determine the incidence of comorbid lung (ILA, bronchiectasis, pulmonary artery enlargement) and non-lung problems (cardiac and aortic c

Первичные конечные точки

• COPD Prevalence [Срок оценки: 15 months]

Вторичные конечные точки (3)

• Severity of COPD [Срок оценки: 15 months]
• Demographic Characteristics [Срок оценки: 15 months]
• Incidence of Comorbid Lung and Non-lung Problems [Срок оценки: 15 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Temple University Of the Commonwealth System of Higher Education — Philadelphia

Идентификаторы

NCT: NCT06933758 · THCI 2.0 RESEARCH PLAN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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