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Search / Trial NCT01678222

The COX-2 Gene and the Immune System

Launched by NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) · Aug 30, 2012

Trial Information

Current as of June 04, 2025

Completed

Keywords

Lymphocyte Prostaglandin Endoperoxidase Synthase 2 Cox 2 Natural History

ClinConnect Summary

This is a cross-sectional, controlled study designed to investigate the association of single nucleotide polymorphisms (SNPs) in the cyclooxygenase-2 (COX2) gene, also called prostaglandin endoperoxidase synthase 2 (PTGS2), on T-cell differentiation and function. Specifically, the impact of the promoter-region SNP 765G\>C (rs20417) and the 3 untranslated region (UTR) SNP 8473T\>C (rs5275) on T helper cell (Th) 2, Th9, and Th17 differentiation and function will be examined. Non-Hispanic, White or Black/African American, non-pregnant adults, aged 18-65 years, who are wild type (WT), with resp...

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • Participant of the Environmental Polymorphisms Registry and current contact information available
  • * Genotype information available for relevant 765G\>C and 8473T\>C COX2 polymorphisms, which indicates:
  • Individuals who are WT with respect to both 765G\>C and 8473T\>C (N=31)
  • Individuals who are WT with respect to 765G\>C and homozygous for 8473T\>C (N=31)
  • Individuals who are homozygous for both 765G\>C and 8473T\>C (N=31)
  • Age 18- 65 years
  • Race self-identified as White or Black and Non-Hispanic ethnicity
  • Willing and able to provide informed consent
  • Able to comply with all protocol procedures
  • EXCLUSION CRITERIA:
  • History of infection within the preceding 1 week or an oral temperature \>38 degrees C
  • Current daily or chronic use of corticosteroids (systemic, inhaled and topical).
  • Any current conditions known to impact peripheral white blood cell count (e.g., leukemia, lymphopenia, AIDS, other immunodeficiency disorders)
  • Current daily or chronic use of systemic immunosuppressants.
  • Current pregnancy or lactation
  • * Unwilling or unable to:
  • Fast (including alcohol and caffeine-containing products) and discontinue tobacco use for 12 hours prior to the study visit
  • Withhold all prescribed and over-the-counter medications and supplements the morning of the study visit, until after the visit is completed
  • * Refrain from taking the following medications and supplements for 7 days prior to the study visit:
  • NSAIDs
  • Corticosteroids (nasal, inhaled, topical or systemic)
  • Fish oil and niacin supplements
  • For blood draws that exceed 200ml, a hematocrit of \<34% for women or \<36% for men, or \>56% for either gender.
  • For blood draws exceeding 200ml, blood or plasma donation in the last 8 weeks

About National Institute Of Environmental Health Sciences (Niehs)

The National Institute of Environmental Health Sciences (NIEHS) is a leading research entity within the National Institutes of Health (NIH) dedicated to understanding the impacts of environmental factors on human health. NIEHS conducts and supports innovative clinical trials aimed at elucidating the relationships between environmental exposures and various health outcomes, fostering advancements in public health and disease prevention. By integrating cutting-edge research with community engagement, NIEHS strives to translate scientific findings into actionable health policies and practices, promoting a healthier environment for all.

Locations

Research Triangle Park, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Darryl C Zeldin, M.D.

Principal Investigator

National Institute of Environmental Health Sciences (NIEHS)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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