RECRUITING

Study of the Effect of Innate on the Inflammatory Response to Endotoxin

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Conditions

AsthmaAtherosclerosisMetabolic SyndromeInsulin ResistanceCancerEndotoxinInnate ImmunityNatural HistoryHealthy VolunteerHV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: \- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers. Objectives: \- To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * The study will involve one visit of 45 to 60 minutes. * Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking. * Participants will provide a blood sample for research purposes.

Official Title

Study of the Effect of Innate Immunity on the Inflammatory Response to Endotoxin

Quick Facts

Study Start:2012-07-30
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01143480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female 18 years of age or older
  2. * Participants must be able to understand and provide written informed consent to participate in the study
  3. * Participants must be able to travel to the CRU
  4. * Willing and able to fast after midnight the night prior to their study appointment
  5. * Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).
  1. * Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)
  2. * Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit
  3. * Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)
  4. * Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)
  5. * Current treatment for cancer with chemotherapy or radiation
  6. * Confirmed or suspected immunosuppressive or immunodeficient condition
  7. * GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies
  8. * Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \>200 ng/mL at visit)
  9. * Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit
  10. * Body weight \< 50 kg (\<110 lbs)
  11. * Temperature \> 37.6 C; blood pressure \< 90/50 mm Hg or \> 170/95 mm Hg; pulse rate \< 50 or \>100 beats/minute
  12. * Pregnant or suspected pregnancy
  13. * Chronic Kidney Disease

Contacts and Locations

Study Contact

NIEHS Join A Study Recruitment Group
CONTACT
(855) 696-4347
myniehs@nih.gov
Michael B Fessler, M.D.
CONTACT
(984) 287-4081
fesslerm@niehs.nih.gov

Principal Investigator

Michael B Fessler, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)

Study Locations (Sites)

NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
United States

Collaborators and Investigators

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

  • Michael B Fessler, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Environmental Health Sciences (NIEHS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-07-30
Study Completion DateN/A

Study Record Updates

Study Start Date2012-07-30
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Endotoxin
  • Innate Immunity
  • Natural History
  • Healthy Volunteer
  • HV

Additional Relevant MeSH Terms

  • Asthma
  • Atherosclerosis
  • Metabolic Syndrome
  • Insulin Resistance
  • Cancer