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WTC Chest CT Imaging Archive

Pulmonary Diseases in WTC Workers: Symptoms, Function, and Chest CT Correlates

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03295279
Enrollment
2122
Registered
2017-09-27
Start date
2012-09-01
Completion date
2027-08-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Airway Disease, Interstitial Lung Disease, Lung Cancer

Keywords

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

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.

Detailed description

The goal of this proposal is to characterize WTC-related lower airway disorders, and use novel imaging approaches to the investigation of obesity, one of their most important risk factors for poor clinical outcome and chronicity. To that end, the clinical team will utilize the WTC Pulmonary Evaluation Unit Chest CT Imaging Archive, an already established large imaging database, linked to extensive related databases that include disease symptoms, both pre-WTC and WTC-related occupational exposures, detailed pulmonary function and longitudinal spirometry measurements, visual imaging classification and grading, and quantitative computer assisted method (QCAM) measurements of airway, pulmonary parenchymal, pleural, and cardiovascular abnormalities. During the course of the proposed research project, the clinical team will continue to enrich most sources of data with periodic updates, in order to accrue information on the trajectories of the different clinical, functional, and imaging abnormalities observed in this population, and investigate the role of key adverse risk factors directly, and in collaboration with other investigators. In a related project, the research team will focus on COPD, classifying its severity, investigating its diagnostic stability, progression, and transitions, characterize structural abnormalities as assessed by chest CT imaging, and examine the interaction of WTC-related exposure levels with tobacco smoking on increasing the risk of for the disease. Grant U01 OH010401 was renewed to 6/30/2026. Grant U01 OH011697 proposes (1) to establish the quantitative computed tomography (QCT) characteristics that may differentiate WTC-related from non-WTC-related COPD, (2) investigate characteristics and longitudinal lung function trajectories of WTC patients with pre-COPD, and (3) investigate lung mechanical strain (LMS) as an early QCT marker of lung injury associated with chronic disease and accelerated longitudinal lung function decline. Grant U01 OH012782-01-00 proposes (1) to test the use of added respiratory surveillance tools (diffusion capacity and forced oscillometry) and explore functional markers of disease progression, (2) explore alternate methods to investigate longitudinal functional trajectories, and (3) novel spirometry calibration methods that might facilitate the implementation of spirometry in nonspecialized settings.

Interventions

None listed

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER
University of Pittsburgh
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
National Jewish Health
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Accelerated longitudinal FEV1 decline5 yearsThe clinical team selects spirometries of acceptable quality, and subjects with at least 3 spirometries spanning at least 5 years, to calculate FEV1 slope, which can then be modeled quantitatively. For categorical analyses, the clinical team defines rapid FEV1 decliners and contrast them to normal-and-stable FEV1 subjects, defined as those having an FEV1 above the lower limit of normal at baseline, no bronchodilator response, and FEV1 not changing by more than 25 ml/year on average in either direction.

Secondary

MeasureTime frameDescription
Number of physician diagnosis of incident asthma5 yearsPhysician diagnosis of asthma with onset after WTC occupational exposures.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRafael E. de la Hoz, MD, MPH, MSc

Icahn School of Medicine at Mount Sinai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026