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Not recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03295279

Conditions

Chronic Airway Disease

Interstitial Lung Disease

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Dr. Rafael E de la Hoz and colleagues have performed standardized and computer-assisted readings of all chest CT scans received by WTC workers and volunteers at the Mount Sinai Medical Center between 2003 and 2016. The clinical team sought to assess all findings suggestive of airway, interstitial, and neoplastic disease in a systematic way, and correlate those findings with clinical, functional, and exposure indicators. The study team's research will also involve analyses of longitudinal imaging and functional trends, and characterization of the WTC related lower airway diseases and their risk factors, with a focus on obesity-related imaging markers. The study team also plans to characterize the transitions into chronic obstructive pulmonary disease (COPD) among these workers.

The researchers also propose to test the use of added respiratory surveillance tools and explore functional markers of disease progression, explore alternate methods to investigate longitudinal functional trajectories, and novel spirometry calibration methods that might facilitate the implementation of spirometry in nonspecialized settings.

Conditions

Chronic Airway Disease

Interstitial Lung Disease

Lung Cancer

Study ID

NCT03295279

Start date

Sep 1, 2012

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All subjects will be participants in the screening/monitoring (SMP) and treatment program (TP) sides of the WTC Health Plan Clinical Center Excellence at Mount Sinai Medical Center, the major site, by far of the NY/NJ consortium of this program.

Exclusion Criteria:

  • Special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, will not be involved in this research study.

Study Design

Enrollment

2122 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Accelerated longitudinal FEV1 decline [ Time Frame: 5 years ]

Central Contacts and Locations

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • World Trade Center
  • Quantitative computerized tomography
  • Qualitative computerized tomography of the chest
  • Chronic airway disease
  • Interstitial lung disease
  • Occupational pulmonology
  • Spirometry
  • Forced Oscillometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.