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NCT Number: NCT06933758

Temple Health Chest Initiative (THCI 2.0)

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%.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio

Diagnostic Test

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 calcifications, osteopenia/osteoporosis and for gut abnormalities) identified by LDCT in a patient population at risk for lung cancer and/or COPD Determine the correlation between clinical measurements and imaging biomarkers

Primary outcomes

  1. COPD Prevalence

    Time frame: 15 months

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

Secondary outcomes

  1. Severity of COPD

    Time frame: 15 months

    Determine the severity of COPD identified by FEV1 % predicted

  2. Demographic Characteristics

    Time frame: 15 months

    Describe demographics characteristics of THCI population

  3. Incidence of Comorbid Lung and Non-lung Problems

    Time frame: 15 months

    Determine the incidence of comorbid lung (ILA, bronchiectasis, pulmonary artery

    enlargement) and non-lung problems (cardiac and aortic calcifications,

    osteopenia/osteoporosis and for gut abnormalities) identified by LDCT in a patient

    population at risk for lung cancer and/or COPD

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Miller, BS

CONTACT

[email protected]

215-707-4821

Stephanie Yerkes, BA

CONTACT

[email protected]

215-707-2357

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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