WTC Chest CT Imaging Archive

NCT ID: NCT03295279

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-01

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Chronic Airway Disease Interstitial Lung Disease Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Rafael E. de la Hoz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

212-241-7996

Facility Contacts

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

Role: primary

212-241-7996

References

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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.

Reference Type BACKGROUND
PMID: 27268046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27548615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29797069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29543564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31347281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31254057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21325944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17786467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17693781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31499008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32239319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32843177 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35343066 (View on PubMed)

Related Links

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http://orcid.org/0000-0002-8949-9279/print

Principal investigator's ORCID record

https://reporter.nih.gov/search/MY8RCxAMMU2ClUwp6cBY4Q/project-details/10995057

Principal investigator's RePORT site for Study 24-00850

https://reporter.nih.gov/search/MY8RCxAMMU2ClUwp6cBY4Q/project-details/10848174

Principal investigator's RePORT site for Study 12-00925

https://reporter.nih.gov/search/MY8RCxAMMU2ClUwp6cBY4Q/project-details/10886482

Principal investigator's RePORT site for Study 18-00595

Other Identifiers

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U01OH010401

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01OH011697

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 17-2598

Identifier Type: OTHER

Identifier Source: secondary_id

U01OH012782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 23-2259

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 12-0751

Identifier Type: -

Identifier Source: org_study_id

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