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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Metabolic Disease; Normal Controls

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: NIEHS Join A Study Recruitment Group; Phone Number: (855) 696-4347; Email: myniehs@nih.gov
• Study Contact Backup: Name: Stavros Garantziotis, M.D.; Phone Number: (984) 287-4412; Email: garantziotis@mail.nih.gov

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • Recruiting
      • NIEHS Clinical Research Unit (CRU)
      • Contact: NIEHS Join A Study Recruitment Group; Phone Number: 855-696-4347; Email: myniehs@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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).

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Stavros Garantziotis, M.D., National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: February 22, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Natural History; Metabolic Disease; Blood Collection
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Metabolic Diseases
• Other Study ID Numbers: 10000152; 000152-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: .Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No