InflammationNCT04888923
Natural History of the Human Biological Response to Environmental Exposure and Injury
An observational study of Inflammation and Normal Controls, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Normal Controls, Metabolic Disease
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 31 Dec 2031
- Phase
- Observational
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The general community sample will be from Durham, Raleigh, Chapel Hill and other nearby cities close to the NIEHS Clinical Research Unit (CRU).
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to provide informed consent.
- Able to read and speak English
- Male or female, aged >=18
- Able to travel to the NIEHS CRU for study visits or travel to an offsite event or conference.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Not willing to have samples stored for future use.
- Current pregnancy or lactation, by participant verbal confirmation.
- Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.
- Participants will be enrolled according to pre-defined host (e.g. disease, genetic, or demographic) or environmental (exposure) characteristics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
NIEHS Join A Study Recruitment Group, 855-696-4347, myniehs@nih.gov
About this study
Official title: Natural History of The Human Biological Response to Environmental Exposure and Injury
Background:
Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.
Read more
Objective:
To identify and understand how environmental exposures contribute to human disease.
Eligibility:
Healthy adults ages 18 and older
Design:
Participants will be screened with questions about their health history, demographics, and medicines they take.
Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.
Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.
Participants may have their nasal passages brushed, scraped, or washed.
Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup.
Participants who produce sperm may give samples.
Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.
Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests.
Participants may collect household dust, urine, or stool at home.
Participants will complete surveys about their health, diet, and exposures.
Participation will last for one or more study visits.
Participants may be contacted in the future to take part in other studies.
Read the detailed description
Study Description:
Environmental exposures such as pollution, diet, stress, etc. contribute to the development and exacerbation of human disease. Understanding the mechanisms of environmentally induced injury and inflammation will allow us to devise better prophylaxis and treatment measures.
Subjects may undergo sampling of (including but not limited to:) blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, sperm samples, skin cells, and/or sputum etc., and may answer predefined questionnaires regarding health and exposures.
Studies which may be performed on collected material includes establishment of cell cultures and immunologic studies.
Objectives:
Primary Objective: To identify the interaction of host and environmental factors in the response to injury and the development of disease.
Secondary Objectives: To develop better methodological tools in order to quantify host-environmental interactions in health and disease.
Endpoints:
Primary Endpoint: Biological markers of cell/tissue injury and inflammation, such as inflammatory cytokines, intracellular kinases or DNA/RNA damage in association with in vitro or in vivo environmental exposures.
Secondary Endpoints: Diseases or pathological processes (e.g. abnormal laboratory values) associated with environmental exposures.
- Conditions
- Inflammation, Normal Controls, Metabolic Disease
- Keywords
- Blood Collection, Metabolic Disease, Inflammation, Natural History
- Medical subject headings
- Inflammation, Metabolic Diseases
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 |
|---|---|---|
| Healthy Controls | General public population, including females and males, who are over the age of 18, with a mixture of races and ethnicities representative of North Carolina. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the interaction of host and environmental factors in the response to injury and the development of disease.
To identify the interaction of host and environmental factors in the response to injury and the development of disease.
Measured: On-going
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start16 Nov 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lawrence S Kirschner, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888923
- Sponsor's protocol ID
- 10000152
- Other IDs
- 000152-E
- Status last verified
- 30 Jul 2026
- First submitted
- 14 May 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.