Recruiting

Computed Tomography

Sponsor:

Northwestern University

Code:

NCT07932717

Conditions

Respiratory Illness

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Low Dose CT scan

Study Details

Brief summary:

Respiratory illnesses are a leading cause of morbidity and mortality worldwide, yet their prevalence in the general population remains poorly characterized. Computed tomography (CT) is the most effective diagnostic tool for identifying respiratory illnesses that cause changes to the lung parenchyma, such as pulmonary infections, fibrosis, and nodules. The diagnostic power of CT led the US Preventive Services Task Force (USPSTF) to issue lung cancer screening guidelines. In this prospective, observational cohort study, the study team will recruit 10,000 individuals aged 21 to 85 years, stratified into three cohorts: Cohort 1 (Medical Indication Group), Cohort 2 (Guideline-Based Screening Group), and Cohort 3 (Asymptomatic Research Low-Dose CT \[LDCT\] Group). The primary analysis will estimate the baseline cross-sectional prevalence of LDCT-detectable pulmonary findings in Cohort 3. Secondary analyses will compare baseline LDCT findings across all three cohorts and evaluate baseline associations between risk/exposure variables and CT findings. Exploratory follow-up analyses will use clinical data from the electronic health record (EHR), as available, for up to 5 years after the baseline/index CT. This study has the potential to transform health screening strategies, reduce disease burden, and improve health outcomes across diverse populations.

Conditions

Respiratory Illness

Study ID

NCT07932717

Start date

Sep 16, 2025

Status verified date

Nov, 2026

Completion date

Dec 30, 2031

Anticipated

Primary completion date

Sep 16, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

All Cohorts:

•Adults 21 through 85 years of age.

Cohort 1:

•Clinical indication for chest CT, such as suspected lung pathology, abnormal chest imaging, or pulmonary symptoms requiring further evaluation. Cohort 1 activities are routine clinical care; research activity is secondary data use.

Cohort 2:

•Individuals who currently meet USPSTF criteria for LDCT lung cancer screening. Cohort 2 activities are routine clinical care; research activity is secondary data use.

Cohort 3:

  • Asymptomatic individuals who:
  • Do not have a clinical indication for chest CT
  • Do not meet current USPSTF criteria for LDCT lung cancer screening
  • Able to provide informed consent

Exclusion Criteria:

All Cohorts:

•Individuals below the age of 21 and above the age of 85.

Cohort 3:

  • Meets USPSTF guideline-based indications for LDCT lung cancer screening or has a clinical indication for chest CT.
  • Any chest CT within the prior 2 years
  • Pregnancy
  • In active surveillance or treatment for a current cancer diagnosis, or a recent cancer diagnosis requiring intervention within 5 years of the baseline assessment.
  • Unable to provide informed consent or lacks decision-making capacity
  • McGaw medical students, residents, and fellows, consistent with NU/FSM policy, to reduce coercion or undue influence. Employees may participate only under the safeguards described in the vulnerable populations section.

Study Design

Enrollment

10000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Cohort 1 (Medical Indication Group)

Adults 21 through 85 years of age with a clinical reason for chest CT, such as suspected lung pathology, abnormal chest imaging, or pulmonary symptoms requiring further evaluation. Cohort 1 participants undergo CT and follow-up as part of routine clinical care. Study activity is limited to secondary use of routine-care data under waiver of consent and HIPAA authorization.

no intervention: Cohort 2 (Guideline-Based Screening Group)

Adults 21 through 85 years of age who meet current USPSTF criteria for LDCT lung cancer screening. Cohort 2 participants undergo screening and follow-up as part of routine clinical care. Study activity is limited to secondary use of routine-care data under waiver of consent and HIPAA authorization.

active comparator: Cohort 3 (Asymptomatic Research LDCT Group)

Adults 21 through 85 years of age who are asymptomatic, do not have a clinical indication for chest CT, and do not meet current USPSTF lung cancer screening criteria. Cohort 3 participants will provide informed consent and HIPAA authorization before undergoing a single LDCT of the chest billed to the study.

Interventions

Low Dose CT scan

A low-dose CT scan is an X-ray procedure where a high-speed computer is used to make multiple images of your chest area using the least amount of radiation possible without reducing the diagnostic quality of the exam.

Primary outcome measure

  • Primary Endpoint [ Time Frame: For each patient, routine turnaround of non-critical findings as reported by the radiologist, or up to 1 week. ]

Central Contacts and Locations

Central contacts

Lindsay Summers

312-921-2957lindsay.summers@nm.org

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Lindsay Summers

312-921-2957lindsay.summers@nm.org

Principal Investigator:

Ankit Bharat, MD

More Information

Sponsor

Northwestern University

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.