NCT03295279

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,122

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2012Aug 2027

Study Start

First participant enrolled

September 1, 2012

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

14.9 years

First QC Date

September 25, 2017

Last Update Submit

April 30, 2026

Conditions

Keywords

World Trade CenterQuantitative computerized tomographyQualitative computerized tomography of the chestChronic airway diseaseInterstitial lung diseaseOccupational pulmonologySpirometryForced Oscillometry

Outcome Measures

Primary Outcomes (1)

  • Accelerated longitudinal FEV1 decline

    The 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.

    5 years

Secondary Outcomes (1)

  • Number of physician diagnosis of incident asthma

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (18)

  • 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: 17786467BACKGROUND
  • 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: 17693781BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Zhang Z, San Jose Estepar R, Doucette JT, Weber J, Ross JC, Celedon JC, de la Hoz RE. Quantitative CT metrics of injury patterns among WTC workers on different longitudinal FEV1 trajectory groups. Respir Med. 2026 May;256:108810. doi: 10.1016/j.rmed.2026.108810. Epub 2026 Apr 7.

  • Napier CO, Mbadugha O, Bienenfeld LA, Doucette JT, Lucchini R, Luna-Sanchez S, de la Hoz RE. Obesity and weight gain among former World Trade Center workers and volunteers. Arch Environ Occup Health. 2017 Mar 4;72(2):106-110. doi: 10.1080/19338244.2016.1197174. Epub 2016 Jun 7.

  • de la Hoz RE, Jeon Y, Miller GE, Wisnivesky JP, Celedon JC. Post-traumatic Stress Disorder, Bronchodilator Response, and Incident Asthma in World Trade Center Rescue and Recovery Workers. Am J Respir Crit Care Med. 2016 Dec 1;194(11):1383-1391. doi: 10.1164/rccm.201605-1067OC.

  • de la Hoz RE, Weber J, Xu D, Doucette JT, Liu X, Carson DA, Celedon JC. Chest CT scan findings in World Trade Center workers. Arch Environ Occup Health. 2019;74(5):263-270. doi: 10.1080/19338244.2018.1452712. Epub 2018 May 9.

  • de la Hoz RE, Jeon Y, Reeves AP, San Jose Estepar R, Liu X, Doucette JT, Celedon JC, Nolan A. Increased pulmonary artery diameter is associated with reduced FEV1 in former World Trade Center workers. Clin Respir J. 2019 Oct;13(10):614-623. doi: 10.1111/crj.13067. Epub 2019 Aug 19.

  • de la Hoz RE, Liu X, Celedon JC, Doucette JT, Jeon Y, Reeves AP, San Jose Estepar R. Association of Obesity with Quantitative Chest CT Measured Airway Wall Thickness in WTC Workers with Lower Airway Disease. Lung. 2019 Aug;197(4):517-522. doi: 10.1007/s00408-019-00246-z. Epub 2019 Jun 28.

  • de la Hoz RE. Occupational lower airway disease in relation to World Trade Center inhalation exposure. Curr Opin Allergy Clin Immunol. 2011 Apr;11(2):97-102. doi: 10.1097/ACI.0b013e3283449063.

  • Sigel KM, Xu D, Weber J, Wisnivesky JP, Celedon JC, de la Hoz RE. Prevalence of Pulmonary Nodules Detected by Computed Tomography in World Trade Center Rescue and Recovery Workers. Ann Am Thorac Soc. 2020 Jan;17(1):125-128. doi: 10.1513/AnnalsATS.201907-517RL. No abstract available.

  • de la Hoz RE, Shapiro M, Nolan A, Celedon JC, Szeinuk J, Lucchini RG. Association of low FVC spirometric pattern with WTC occupational exposures. Respir Med. 2020 Aug-Sep;170:106058. doi: 10.1016/j.rmed.2020.106058. Epub 2020 Jun 7.

  • Sigel K, de la Hoz RE, Markowitz SB, Kong CY, Stone K, Todd AC, Wisnivesky JP. Lung cancer incidence among world trade center rescue and recovery workers. Cancer Med. 2022 Aug;11(16):3136-3144. doi: 10.1002/cam4.4672. Epub 2022 Mar 28.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, InterstitialLung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Rafael E. de la Hoz, MD, MPH, MSc

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 27, 2017

Study Start

September 1, 2012

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations