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 : June 13, 2022

Sponsor:

Collaborators:

University of Pittsburgh

Brigham and Women's Hospital

National Jewish Health

University of New Mexico

Information provided by (Responsible Party):

Rafael E. de la Hoz, Icahn School of Medicine at Mount Sinai

Tracking Information

First Submitted Date

September 25, 2017

First Posted Date

September 27, 2017

Last Update Posted Date

June 13, 2022

Actual Study Start Date

January 15, 2012

Estimated Primary Completion Date

June 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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.

Original Primary Outcome Measures

Accelerated longitudinal FEV1 decline [ Time Frame: 5 years ]

The clinical team selects spirometries with a quality graded as A or B, 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 as those losing more than 100 ml/year on average, 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.

Change History

Current Secondary Outcome Measures

Number of physician diagnosis of incident asthma [ Time Frame: 5 years ]

Physician diagnosis of asthma with onset after WTC occupational exposures.

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

WTC Chest CT Imaging Archive

Official Title

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

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.

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.

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition

Chronic Airway Disease
Interstitial Lung Disease
Lung Cancer

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Active, not recruiting

Actual Enrollment

1710

Original Actual Enrollment

1722

Estimated Study Completion Date

June 2026

Estimated Primary Completion Date

June 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

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 )

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

Rafael E. de la Hoz, Icahn School of Medicine at Mount Sinai

Original Responsible Party

Icahn School of Medicine at Mount Sinai

Current Study Sponsor

Icahn School of Medicine at Mount Sinai

Original Study Sponsor

Same as current

Collaborators

University of Pittsburgh
Brigham and Women's Hospital
National Jewish Health
University of New Mexico

Investigators

Principal Investigator:

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

Icahn School of Medicine at Mount Sinai

PRS Account

Icahn School of Medicine at Mount Sinai

Verification Date

June 2022

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