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WTC Chest CT Imaging Archive

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ClinicalTrials.gov Identifier: NCT03295279
Recruitment Status : Active, not recruiting
First Posted : September 27, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease
Chronic Airway Disease Interstitial Lung Disease Lung Cancer

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.

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Study Type : Observational
Actual Enrollment : 1722 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pulmonary Diseases in WTC Workers: Symptoms, Function, and Chest CT Correlates
Actual Study Start Date : January 15, 2013
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases




Primary Outcome Measures :
  1. Accelerated longitudinal FEV1 decline [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. Number of physician diagnosis of incident asthma [ Time Frame: 5 years ]
    Physician diagnosis of asthma with onset after WTC occupational exposures.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295279


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Rafael E. de la Hoz, MD, MPH, MSc Icahn School of Medicine at Mount Sinai

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03295279     History of Changes
Other Study ID Numbers: GCO 12-0751
U01OH010401 ( U.S. NIH Grant/Contract )
U01OH011697 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
World Trade Center
Quantitative computerized tomography
Qualitative computerized tomography of the chest
Chronic airway disease
Interstitial lung disease
Occupational pulmonology

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive