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Natural History of the Human Biological Response to Environmental Exposure and Injury

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ClinicalTrials.gov Identifier: NCT04888923
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Study Description
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Brief 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. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.

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.


Condition or disease
Inflammation Normal Controls Metabolic Disease

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Natural History of The Human Biological Response to Environmental Exposure and Injury
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2031
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. To identify the interaction of host and environmental factors in the response to injury and the development of disease. [ Time Frame: On-going ]
    To identify the interaction of host and environmental factors in the response to injury and the development of disease.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study.
  2. Ability to provide informed consent.
  3. Able to read and speak English.
  4. Male or female, aged greater than or equal to 18.
  5. Able to travel to the NIEHS CRU for study visits.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Not willing to have samples stored for future use.
  2. Current pregnancy or lactation, by participant verbal confirmation.
  3. Any condition that, in the investigator s opinion, places the participant at undue risk for complications associated with required study procedures.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888923


Contacts
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Contact: NIEHS Join A Study Recruitment Group (855) 696-4347 myniehs@nih.gov
Contact: Stavros Garantziotis, M.D. (984) 287-4412 garantziotis@mail.nih.gov

Locations
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United States, North Carolina
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: NIEHS Join A Study Recruitment Group    855-696-4347    myniehs@nih.gov   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Stavros Garantziotis, M.D. National Institute of Environmental Health Sciences (NIEHS)
More Information
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Additional Information:

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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT04888923    
Other Study ID Numbers: 10000152
000152-E
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: February 22, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Blood Collection
Metabolic Disease
Inflammation
Natural History
Additional relevant MeSH terms:
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Metabolic Diseases
Inflammation
Pathologic Processes