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Biological SpecimensNCT02473770

Rapid Acquisition of Pre- and Post-Incident Disaster Data

An observational study of Biological Specimens, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Background: Disasters like earthquakes, floods, and oil spills can give people health problems. Workers who respond to a disaster (like police and firefighters) are directly exposed to contaminants during the emergency response. So they could be at the greatest risk for these problems. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Biological Specimens
How many people
0 participants
Where
1 siteUnited States
Study dates
27 Jan 2021to 27 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Disaster responders deployed to a disaster area to conduct emergency response activities. Disaster responders may include traditional first responders such as police, fire, and emergency medical personnel, as well as non-traditional responder groups such as public health personnel and workers involved in environmental remediation and restoration activities.

Who may be able to join

  • At least 21 years of age
  • Is part of an eligible disaster responder cohort as defined in Section 5 that has received IRB approval for inclusion

Who cannot join

  • -Any conditions that, in the opinion of the Investigator, would pose an unacceptable risk to the participant or to the validity of the study results

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NIEHS Clinical Research Unit (CRU)

    Research Triangle Park, North Carolina, 20892

Other trials in United States

About this study

Official title: Rapid Acquisition of Pre and Post-Incident Disaster Data Study

Background:

  • Disasters like earthquakes, floods, and oil spills can give people health problems. Workers who respond to a disaster (like police and firefighters) are directly exposed to contaminants during the emergency response. So they could be at the greatest risk for these problems. Researchers want to gather data about these workers before and right after they go to a disaster. They hope this will help them understand the health effects of disasters.
Read more

Objectives:

  • To answer questions about the health effects of disaster exposures. To create a participant registry and collect biological samples and health data.

Eligibility:

  • People at least 21 years of age who are sent to a disaster area for an emergency response.

Design:

  • Participants will have 1 study visit.
  • Participants will answer questions about:
  • Contact information
  • Health, lifestyle, emotions
  • Medical history
  • Disaster response activities
  • Things they are exposed to in the environment
  • Participants may have blood collected from a vein in the arm.
  • Participants may give biological samples. These may be urine, saliva, cheek cells, nail clippings, or hair.
  • Participants will have a short physical exam. They may have their hip and waist measured over their clothes. The amount of oxygen in their blood may be measured by a sensor on a finger or ear.
  • Participants may have a lung function test. They will take a deep breath and exhale strongly.
  • Participants will be asked to agree to be contacted later to update contact data and learn about future studies.
Read the detailed description

Disasters are frequently associated with environmental exposures and socioeconomic disruptions that may lead to short- and long-term health consequences. Disaster response workers are potentially at the greatest risk for adverse outcomes due to direct exposure to hazardous environmental contaminants during the emergency response process. The importance of conducting disaster responder research in the immediate aftermath of disasters has become widely recognized, but numerous barriers to doing so have also been recognized. The Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) protocol aims to address this gap by registering and characterizing a cohort of disaster response workers early in the disaster response phase to obtain baseline characteristics. Disaster response workers deployed to a disaster area to conduct emergency response activities will be targeted for enrollment. Disaster responders may include police, fire, and emergency medical personnel, as well as other responder groups such as public health personnel and workers involved in environmental remediation and restoration activities. The primary objective of the RAPIDD study is to create a research registry comprised of disaster response workers who are rostered before or immediately after deployment to a disaster area. Important secondary aims are to administer questionnaires and collect biological samples to characterize the cohort in a manner that will allow for future prospective analyses of associations between disaster exposures and health outcomes. In order to achieve these aims, we have developed a protocol, operational manuals, questionnaires, data collection systems, training plans, and other tools to reduce the time required to initiate disaster research. We will also obtain scientific and regulatory approval of the protocol in advance of the disaster in hopes that expedited amendments, with clarifications of the research, will minimize delays associated with various review cycles.

In order to characterize the cohort prior to their involvement with response activities that could lead to disaster-related exposures, we will attempt to collect a wide range of questionnaire data, clinical measurements and biological samples. Questionnaires may cover topics including contact information, demographics, socioeconomic status, medical history, current physical and mental health status, occupational exposures, alcohol and tobacco use and other lifestyle factors.

Biological specimens collected may include the following: blood, urine, nail clippings, saliva, buccal cells or hair. Clinical measurements may include vital signs, anthropometric measurements and spirometry. By seeking IRB and other regulatory approvals for carrying out this research in advance, we anticipate that we will be able to submit expedited amendments to clarify the research plan for a specific disaster so that research can be initiated early in the response phase. However, in the very early phases of some disaster situations, it may not be safe or feasible to collect the data needed to fully characterize a cohort of response workers. In these situations, data collection may be limited to rostering and limited self-collection of biospecimens. As the response effort stabilizes and more becomes known about potential exposures and related adverse health outcomes, we intend to expand our data collection effort, and we will seek expedited regulatory approval to do so.

Keywords
Registry, Exposures, Biological Specimens, Occupational Health, Exposure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02473770
Study groupRoleWhat they receive
Disaster respondersConducting emergency disaster relief.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Create a research registry comprised of disaster response workers who are rostered before or immediately after deployment to a disaster area.

    This is a registry study conducted to establish and characterize a cohort of disaster responders deployed to a disaster area to conductemergency response activities.

    Measured: On going

Secondary outcomes (3)
  1. Gather sociodemographic, health status, occupational exposure, and lifestyle information of the cohort before or immediately after deployment to a disaster area

    Measured: Ongoing

  2. Collect, process and store biological samples to allow estimations of disaster-related exposures of the disaster response worker cohort before or immediately after deployment to a disaster area

    Measured: Ongoing

  3. Establish a well-characterized disaster response worker cohort that will allow for future analyses of associations between disaster exposures and health outcomes

    Measured: Ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2015 (estimated)
  2. Study start27 Jan 2021
  3. Primary completion27 Jan 2021
  4. Study completion27 Jan 2021

Why it stopped: New prepositioned protocol being developed to optimize its use in the disaster setting and broaden its reach.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473770
Sponsor's protocol ID
999915133
Other IDs
15-E-N133
Status last verified
Jan 2021
First submitted
13 Jun 2015
Last updated
1 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lurie N, Manolio T, Patterson AP, Collins F, Frieden T. Research as a part of public health emergency response. N Engl J Med. 2013 Mar 28;368(13):1251-5. doi: 10.1056/NEJMsb1209510. No abstract available.

    PubMed 23534565

Questions about this trial

What is this clinical trial studying?

An observational study of Biological Specimens, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Create a research registry comprised of disaster response workers who are rostered before or immediately after deployment to a disaster area. (time frame: On going). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473770, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.

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