The COX-2 Gene and the Immune System
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ClinicalTrials.gov Identifier: NCT01678222 |
Recruitment Status :
Completed
First Posted : September 3, 2012
Last Update Posted : March 5, 2021
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Background:
- The immune system contains several different types of cells in the blood and other parts of the body. The body can fight infections well with the right balance of these cell types. The wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2 gene may help decide the balance of cell types that the body makes as part of the immune system. It may also play a role in certain immune system diseases. Researchers want to see how COX-2 affects the cells in the immune system.
Objectives:
- To study how the COX-2 gene works in the body s immune system.
Eligibility:
- Individuals 18 years of age and above who are part of the Environmental Polymorphisms Registry.
Design:
- Participants will have one study visit at the National Institutes of Health. They will collect a urine sample at home on the morning of the study visit.
- Participants will have a physical exam and medical history. They will provide a blood sample. They will also give researchers the urine sample they collected that morning.
- No treatment will be provided as part of this study.
Condition or disease |
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Allergic Inflammation Asthma |
Study Type : | Observational |
Actual Enrollment : | 117 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | The Role of Functionally Relevant Cyclooxygenase-2 (COX-2) Gene Single Nucleotide Polymorphisms -765G>C and 8473T>C in Lymphocyte Differentiation |
Actual Study Start Date : | May 2, 2013 |

Group/Cohort |
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SNP
individuals who are homozygous for either the major or minor variant of both SNPs
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- To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo [ Time Frame: Ongoing ]To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
- To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo [ Time Frame: Ongoing ]To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo

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Ages Eligible for Study: | 18 Years to 150 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
- Participant of the Environmental Polymorphisms Registry and current contact information available
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678222
United States, North Carolina | |
NIEHS Clinical Research Unit (CRU) | |
Research Triangle Park, North Carolina, United States |
Principal Investigator: | Darryl C Zeldin, M.D. | National Institute of Environmental Health Sciences (NIEHS) |
Publications:
Responsible Party: | National Institute of Environmental Health Sciences (NIEHS) |
ClinicalTrials.gov Identifier: | NCT01678222 |
Other Study ID Numbers: |
120190 12-E-0190 |
First Posted: | September 3, 2012 Key Record Dates |
Last Update Posted: | March 5, 2021 |
Last Verified: | January 13, 2021 |
Lymphocyte Prostaglandin Endoperoxidase Synthase 2 COX-2 |
Inflammation Pathologic Processes |