NYU/Bellevue WTC Health Impacts Research Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01751711
First received: December 14, 2012
Last updated: January 23, 2014
Last verified: March 2013
  Purpose

The destruction of the World Trade Center (WTC) resulted in long-term adverse health effects for workers and volunteers involved in rescue and recovery (2002; 2004a; 2004b; Skloot et al. 2004). In addition, increasing data demonstrate persistent adverse health effects for local residents as well as for the responders (Lin in press; Reibman 2004).

Screening programs for responders, funded by the CDC-NIOSH have included extensive medical, mental and exposure histories, combined with physical examinations, chest x-rays, and spirometry Screening programs for health effects in residents have been much more limited and have only studied selective populations; to date, our studies are the most comprehensive - and consisted of simple questionnaires with limited spirometry. The results of these studies, have now led to the recognition of extensive adverse health outcomes in the residential, as well as the worker and volunteer populations.

Despite this information, many individuals, workers as well as residents, may not recognize that their ailments may be related to WTC exposures. Few programs exist that educate these populations as well as provide supportive services for medical treatment. Individuals with medical insurance may have sought care among health care providers but many individual practitioners have varying expertise in the predominantly pulmonary and mental health disorders experienced by these populations. Those lacking insurance may have gone untreated. The goal of this application will therefore be to address this unmet need by providing a multi-disciplined, comprehensive evaluation and treatment program for individuals with suspected World Trade Center-related health issues.

Target populations who will participate in the Bellevue Hospital Red Cross WTC Health Impacts Program will include:

  • residents (children and adults) of Lower Manhattan communities at the time of the attacks, who remained or returned to their homes soon after the attacks
  • individuals involved in debris removal in surrounding commercial and residential buildings,
  • individuals involved in rescue, recovery and debris removal who have been previously screened through the World Trade Center Worker and Volunteer Medical Screening Program and are in need of continued treatment.

Goals of the Bellevue Red Cross WTC Health Impacts program will be to provide:

  • Medical evaluation and treatment for suspected WTC-associated illness Initial medical evaluation or medical consultation with an integrated mental health and social service needs assessment Subspecialty testing or consultation for diagnosis and further evaluation of suspected WTC-associated illness

    • Treatment for WTC-associated limited or prolonged illness
    • Development of a multi-discipline referral program with preferred practitioners for:

      1. Specialty care health needs
      2. Primary care health needs
      3. Mental health care needs
  • Collaboration with WTC Worker and Volunteer Medical Screening and Monitoring Program to develop practice suggestions for further evaluation and diagnostic testing, interpretation of testing, and treatment of individuals with suspected WTC-associated health problems

Condition
Effects of World Trade Center Attacks (9/11)

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Tracking the development pulmonary disease post-WTC disaster events of September 11, 2001. [ Time Frame: Since 2001 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

N/A - Research registry to track development of disease and diagnosis of patients exposed to post-9/11 WTC dust


Estimated Enrollment: 8000
Study Start Date: August 2005
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The populations to be served will consist predominantly of a) local residents who were impacted by the dispersion of the WTC dusts and fumes, b) individuals involved in cleaning and debris removal of local commercial spaces, and c) responders to the WTC collapse. These populations will be recruited from past and ongoing programs that we have developed as well as from ongoing collaborations with community organizations that include: the Beyond Ground Zero Network, 9/11 Environmental Action committee, and the WTC Residents Coalition. In addition, we will collaborate with the Charles B. Wang Community Health Center and the centers involved in the ongoing WTC Workers and Volunteer Medical Screening and Monitoring Program.

Criteria

Inclusion Criteria:

  • individuals with suspected World Trade Center (WTC)-related health problems.

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751711

Contacts
Contact: Joan Reibman, MD 212-263-6479 joan.reibman@nyumc.org

Locations
United States, New York
Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Bellevue Asthma Clinic    212-562-1734      
Principal Investigator: Joan Reibman, MD         
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01751711     History of Changes
Other Study ID Numbers: NCT00404898, 200-2011-39391
Study First Received: December 14, 2012
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board (IRB)

Keywords provided by New York University School of Medicine:
WTC dust
Asthma
9/11

ClinicalTrials.gov processed this record on July 20, 2014