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WTC Chest CT Imaging Archive

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
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
 (submitted: May 10, 2019)
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
 (submitted: September 25, 2017)
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
 (submitted: September 25, 2017)
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
 (submitted: June 9, 2022)
1710
Original Actual Enrollment
 (submitted: September 25, 2017)
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 No
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: No
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