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Enrolling by invitation NCT03295279

WTC Chest CT Imaging Archive

Observational Chronic Airway Disease Interstitial Lung Disease Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Airway Disease, Interstitial Lung Disease, Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Accelerated longitudinal FEV1 decline [Time frame: 5 years]
Secondary outcome measures (1)
  • Number of physician diagnosis of incident asthma [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Publications

  • de la Hoz RE, Shohet MR, Chasan R, Bienenfeld LA, Afilaka AA, Levin SM, Herbert R. Occupational toxicant inhalation injury: the World Trade Center (WTC) experience. Int Arch Occup Environ Health. 2008 Feb;81(4):479-85. doi: 10.1007/s00420-007-0240-x. Epub 2007 Sep 5. PMID 17786467
  • Mendelson DS, Roggeveen M, Levin SM, Herbert R, de la Hoz RE. Air trapping detected on end-expiratory high-resolution computed tomography in symptomatic World Trade Center rescue and recovery workers. J Occup Environ Med. 2007 Aug;49(8):840-5. doi: 10.1097/JOM.0b013e3180d09e87. PMID 17693781
  • de la Hoz RE, Liu X, Doucette JT, Reeves AP, Bienenfeld LA, Wisnivesky JP, Celedon JC, Lynch DA, San Jose Estepar R. Increased Airway Wall Thickness is Associated with Adverse Longitudinal First-Second Forced Expiratory Volume Trajectories of Former World Trade Center workers. Lung. 2018 Aug;196(4):481-489. doi: 10.1007/s00408-018-0125-7. Epub 2018 May 24. PMID 29797069
  • Weber J, Reeves AP, Doucette JT, Jeon Y, Sood A, San Jose Estepar R, Celedon JC, de la Hoz RE. Quantitative CT Evidence of Airway Inflammation in WTC Workers and Volunteers with Low FVC Spirometric Pattern. Lung. 2020 Jun;198(3):555-563. doi: 10.1007/s00408-020-00350-5. Epub 2020 Apr 1. PMID 32239319
  • Liu X, Reeves AP, Antoniak K, San Jose Estepar R, Doucette JT, Jeon Y, Weber J, Xu D, Celedon JC, de la Hoz RE. Association of quantitative CT lung density measurements and lung function decline in World Trade Center workers. Clin Respir J. 2021 Jun;15(6):613-621. doi: 10.1111/crj.13313. Epub 2020 Dec 29. PMID 33244876
  • de la Hoz RE, Shapiro M, Nolan A, Sood A, Lucchini RG, Cone JE, Celedon JC. Association of World Trade Center (WTC) Occupational Exposure Intensity with Chronic Obstructive Pulmonary Disease (COPD) and Asthma COPD Overlap (ACO). Lung. 2023 Aug;201(4):325-334. doi: 10.1007/s00408-023-00636-4. Epub 2023 Jul 19. PMID 37468611
  • de la Hoz RE, Jeon Y, Doucette JT, Reeves AP, San Jose Estepar R, Celedon JC. Cluster Analysis of World Trade Center Related Lower Airway Diseases. J Occup Environ Med. 2024 Feb 1;66(2):179-184. doi: 10.1097/JOM.0000000000003023. Epub 2023 Nov 29. PMID 38305727
  • Weber J, Zhang Z, Doucette JT, Sood A, Celedon JC, de la Hoz RE. Spirometric pattern transitions in a World Trade Center occupational cohort on longitudinal surveillance. Respir Med. 2025 Aug;244:108170. doi: 10.1016/j.rmed.2025.108170. Epub 2025 May 21. PMID 40409739

Identifiers

NCT: NCT03295279 · GCO 12-0751 · U01OH010401 · U01OH011697 · GCO 17-2598 · U01OH012782 · GCO 23-2259

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗