WTC Chest CT Imaging Archive
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03295279 |
Recruitment Status :
Active, not recruiting
First Posted : September 27, 2017
Last Update Posted : June 13, 2022
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Condition or disease |
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Chronic Airway Disease Interstitial Lung Disease Lung Cancer |
Study Type : | Observational |
Actual Enrollment : | 1710 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, 2012 |
Estimated Primary Completion Date : | June 2026 |
Estimated Study Completion Date : | June 2026 |

- 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.
- 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 |
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.

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
United States, New York | |
Icahn School of Medicine at Mount Sinai | |
New York, New York, United States, 10029 |
Principal Investigator: | Rafael E. de la Hoz, MD, MPH, MSc | Icahn School of Medicine at Mount Sinai |
Publications of Results:
Other Publications:
Responsible Party: | Rafael E. de la Hoz, Professor, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT03295279 |
Other Study ID Numbers: |
GCO 12-0751 U01OH010401 ( U.S. NIH Grant/Contract ) U01OH011697 ( U.S. NIH Grant/Contract ) GCO 17-2598 ( Other Identifier: Icahn School of Medicine at Mount Sinai ) |
First Posted: | September 27, 2017 Key Record Dates |
Last Update Posted: | June 13, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
World Trade Center Quantitative computerized tomography Qualitative computerized tomography of the chest |
Chronic airway disease Interstitial lung disease Occupational pulmonology |
Lung Diseases Lung Diseases, Interstitial Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Lung Diseases, Obstructive |