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.
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
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.
- Conditions
- Biological Specimens
- 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 group | Role | What they receive |
|---|---|---|
| Disaster responders | Conducting emergency disaster relief. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Gather sociodemographic, health status, occupational exposure, and lifestyle information of the cohort before or immediately after deployment to a disaster area
Measured: Ongoing
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
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.
- First posted17 Jun 2015 (estimated)
- Study start27 Jan 2021
- Primary completion27 Jan 2021
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biological SpecimensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stavros Garantziotis, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Acquisition of Pre and Post-Incident Disaster Data Study
- ClinicalTrials.gov ID
- NCT02473770
- Acronym / sponsor ID
- 999915133
- Conditions
- Biological Specimens
- Keywords
- Registry, Exposures, Biological Specimens, Occupational Health, Exposure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: New prepositioned protocol being developed to optimize its use in the disaster setting and broaden its reach.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disaster responders | – | –Conducting emergency disaster relief. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
This is a registry study conducted to establish and characterize a cohort of disaster responders deployed to a disaster area to conductemergency response activities.
3 secondary outcomes
Gather sociodemographic, health status, occupational exposure, and lifestyle information of the cohort before or immediately after deployment to a disaster area
Time frame: Ongoing
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
Time frame: Ongoing
Establish a well-characterized disaster response worker cohort that will allow for future analyses of associations between disaster exposures and health outcomes
Time frame: Ongoing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 23534565Lurie 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.
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Sample Collection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Garantziotis, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
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.