ClinicalTrials.gg
RecruitingNCT06933758Updated Apr 18, 2025

Temple Health Chest Initiative (THCI 2.0)

An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Temple University. Recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Temple University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University — 5 open to participants now, 5 under way, none of them phase 3. Pulmonary Disease, Chronic Obstructive · Temple University.

Started
2025
the only one that year
Observational
2 of 12
1 open now
Registered
12th of 12
by date

Among the 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University, this one is the only one that started in 2025, is one of 2 observational ones, and was the 12th registered.

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

5 of the 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Pulmonary Disease, Chronic Obstructive by Temple University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • COPD
04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 50; over 80 years old
  • No lung cancer screening
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pulmonary function testing

    If the patient does have airflow obstruction (any severity) they will be contacted to complete additional questionnaires.

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

Interventions

  • Diagnostic testDetermine 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 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for May 2026, 15 months after the start.

Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's planned 15 months is below that.

Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2025
First posted
Apr 18, 2025
StartActual
Feb 28, 2025
Primary completionEst.
May 31, 2026
CompletionEst.
Jun 30, 2026
Last update
Apr 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06933758
Lead sponsor
Temple University
Responsible party
Sponsor
First posted
Apr 18, 2025
Start date
Feb 28, 2025
Primary completion
May 31, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 18, 2025

Study contacts

Lauren Miller, BS
Contact
lauren.e.miller@temple.edu
215-707-4821
Stephanie Yerkes, BA
Contact
stephanie.yerkes@temple.edu
215-707-2357
Gerard Criner, MD
principal investigator · Temple University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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