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

NCT04888923 | Recruiting

• 2 other identifiers: 10000152000152-E
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Controls; Metabolic Disease; Inflammation

Keywords

Blood Collection; Metabolic Disease; Inflammation; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  On-going

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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 greater than or equal to 18.
• Able to travel to the NIEHS CRU for study visits.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Inflammation; Metabolic Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Lawrence S Kirschner, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Lawrence S Kirschner, M.D.

CONTACT

(984) 287-3562; lawrence.kirschner@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 17, 2021
• Study Start: November 16, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 16, 2026

Record last verified: 2026-07-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)