Temple Health Chest Initiative (THCI 2.0)

NCT06933758 | Recruiting

• 1 other identifier: THCI 2.0 RESEARCH PLAN
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

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.

  15 months

Secondary Outcomes (3)

• Severity of COPD

  15 months

• Demographic Characteristics

  15 months

• Incidence of Comorbid Lung and Non-lung Problems

  15 months

Study Arms (1)

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

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

Pulmonary function testing

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Of the Commonwealth System of Higher Education

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tomography, X-Ray Computed; Symptom Assessment

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Gerard Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Miller, BS

CONTACT

215-707-4821; lauren.e.miller@temple.edu

Stephanie Yerkes, BA

CONTACT

215-707-2357; stephanie.yerkes@temple.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: April 18, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-01

Locations

US (1)