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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• To identify the interaction of host and environmental factors in the response to injury and the development of disease. [Срок оценки: On-going]

Критерии участия

• INCLUSION CRITERIA:

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• NIEHS Clinical Research Unit (CRU) — Research Triangle Park

Идентификаторы

NCT: NCT04888923 · 10000152 · 000152-E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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