deltatrials
Recruiting OBSERVATIONAL NCT04888923

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

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

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Updated 37 times since 2021 Last updated: Apr 11, 2026 Started: Nov 16, 2021 Primary completion: Dec 31, 2031 Completion: Dec 31, 2031
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Inflammation and Metabolic Disease and is currently actively recruiting participants. National Institute of Environmental Health Sciences (NIEHS) leads this study, which shows 37 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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 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.

Status Flow

~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Apr 2023 · 4 months · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jan 2024 · 7 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Mar 2025 · 3 months · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~Jun 2025 · 2 months · monthly snapshot~Jun 2025 – ~Aug 2025 · 2 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Apr 2026 · 2 months · monthly snapshotApr 16, 2026 – present · 3 months · daily API

Change History

37 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Recruiting

  2. Feb 2026 — Apr 2026 [monthly]

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  3. Jan 2026 — Feb 2026 [monthly]

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  4. Dec 2025 — Jan 2026 [monthly]

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  5. Sep 2025 — Dec 2025 [monthly]

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Show 32 earlier versions
  1. Aug 2025 — Sep 2025 [monthly]

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  2. Jun 2025 — Aug 2025 [monthly]

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  3. Apr 2025 — Jun 2025 [monthly]

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  4. Mar 2025 — Apr 2025 [monthly]

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  5. Dec 2024 — Mar 2025 [monthly]

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  6. Nov 2024 — Dec 2024 [monthly]

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  7. Oct 2024 — Nov 2024 [monthly]

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  8. Sep 2024 — Oct 2024 [monthly]

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  9. Aug 2024 — Sep 2024 [monthly]

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  11. Jun 2024 — Jul 2024 [monthly]

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  12. May 2024 — Jun 2024 [monthly]

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  13. Apr 2024 — May 2024 [monthly]

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  14. Mar 2024 — Apr 2024 [monthly]

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  15. Feb 2024 — Mar 2024 [monthly]

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  16. Jan 2024 — Feb 2024 [monthly]

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  17. Jun 2023 — Jan 2024 [monthly]

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  18. May 2023 — Jun 2023 [monthly]

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  19. Apr 2023 — May 2023 [monthly]

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  20. Dec 2022 — Apr 2023 [monthly]

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  21. Sep 2022 — Dec 2022 [monthly]

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  22. Jul 2022 — Sep 2022 [monthly]

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  23. Jun 2022 — Jul 2022 [monthly]

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  24. May 2022 — Jun 2022 [monthly]

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  25. Apr 2022 — May 2022 [monthly]

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  26. Mar 2022 — Apr 2022 [monthly]

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  27. Jan 2022 — Mar 2022 [monthly]

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  28. Dec 2021 — Jan 2022 [monthly]

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  29. Nov 2021 — Dec 2021 [monthly]

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  30. Oct 2021 — Nov 2021 [monthly]

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  31. Sep 2021 — Oct 2021 [monthly]

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  32. Jun 2021 — Sep 2021 [monthly]

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    First recorded

Eligibility 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. ...

Contact Information

Sponsor contact:
  • National Institute of Environmental Health Sciences (NIEHS)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .