Chronic Obstructive Pulmonary Disease (COPD)NCT06933758
Temple Health Chest Initiative (THCI 2.0)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Temple University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 50 to 80 years old * screened for early lung cancer using low dose CT imaging
Who may be able to join
- 50 to 80 years old
- Screened for early lung cancer using low dose CT imaging
Who cannot join
- Under 50; over 80 years old
- No lung cancer screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple University Of the Commonwealth System of Higher Education
Philadelphia, Pennsylvania, 19140
Lauren Miller, BS, 215-707-4821, lauren.e.miller@temple.edu
Stephanie Yerkes, BA, 215-707-2357, stephanie.yerkes@temple.edu
About this study
Official title: Temple Health Chest Initiative (THCI 2.0) - Lung Cancer Screening Project With COPD Detection
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%.
Read the detailed description
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.
- Being tested
- Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatioDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary function testing | If the patient does have airflow obstruction (any severity) they will be contacted to complete additional questionnaires. Receives: Diagnostic Test: Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatio |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Prevalence
Determine COPD prevalence utilizing < 0.7 FEV1/FVC plus evidence of emphysema by quantitated HRCT in the THCI lung cancer screening population.
Measured: 15 months
Secondary outcomes (3)
Severity of COPD
Determine the severity of COPD identified by FEV1 % predicted
Measured: 15 months
Demographic Characteristics
Describe demographics characteristics of THCI population
Measured: 15 months
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start28 Feb 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Criner, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933758
- Sponsor's protocol ID
- THCI 2.0 RESEARCH PLAN
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temple Health Chest Initiative (THCI 2.0) - Lung Cancer Screening Project With COPD Detection
- ClinicalTrials.gov ID
- NCT06933758
- Acronym / sponsor ID
- THCI 2.0 RESEARCH PLAN
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary function testing | – | Diagnostic Test: Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatioIf the patient does have airflow obstruction (any severity) they will be contacted to complete additional questionnaires. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 50 to 80 years old * screened for early lung cancer using low dose CT imaging
Key inclusion criteria (2 listed)
- 50 to 80 years old
- Screened for early lung cancer using low dose CT imaging
Key exclusion criteria (2 listed)
- Under 50; over 80 years old
- No lung cancer screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine COPD prevalence utilizing spirometry along with CT scans and symptom assessments in the THCI lung cancer screening populatioDemonstrate 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 | Diagnostic test | Pulmonary function testing |
Primary outcome
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.
3 secondary outcomes
Severity of COPD
Time frame: 15 months
Demographic Characteristics
Time frame: 15 months
Incidence of Comorbid Lung and Non-lung Problems
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerard Criner, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Miller, BS (215-707-4821, lauren.e.miller@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Prevalence (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.