Health TrialsbyHealthPanel

Temple Health Chest Initiative (THCI 2.0)

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorTemple University

About this trial

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%.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

50 to 80 years old

Screened for early lung cancer using low dose CT imaging

Disqualifiers

Under 50; over 80 years old

No lung cancer screening

Trial population

* 50 to 80 years old * screened for early lung cancer using low dose CT imaging

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Pulmonary function testing1 intervention

Trial outcomes

Primary outcomes

1

COPD Prevalence

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

Time frame
15 months

Secondary outcomes

1

Severity of COPD

Determine the severity of COPD identified by FEV1 % predicted

Time frame
15 months
2

Demographic Characteristics

Describe demographics characteristics of THCI population

Time frame
15 months
3

Incidence of Comorbid Lung and Non-lung Problems

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

Time frame
15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Temple University

Lead sponsor

Source ClinicalTrials.gov
Apply now