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Protocol Details

The Role of Functionally Relevant Cyclooxygenase-2 (COX-2) Gene Single Nucleotide Polymorphisms - 765G>C and 8473T>C in Lymphocyte Differentiation

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-E-0190

Sponsoring Institute

National Institute of Environmental Health Sciences (NIEHS)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 150

Referral Letter Required

Yes

Population Exclusion(s)

Children;
American Indian or Alaskan Native;
Asian;
Hispanic or Latino

Keywords

Lymphocyte;
Prostaglandin Endoperoxidase Synthase 2;
COX-2;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Allergic Inflammation;
Asthma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Environmental Health Sciences

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.

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Eligibility

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


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Citations:

Li H, Bradbury JA, Dackor RT, Edin ML, Graves JP, DeGraff LM, Wang PM, Bortner CD, Maruoka S, Lih FB, Cook DN, Tomer KB, Jetten AM, Zeldin DC. Cyclooxygenase-2 regulates Th17 cell differentiation during allergic lung inflammation. Am J Respir Crit Care Med. 2011 Jul 1;184(1):37-49.

McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci U S A. 1999 Jan 5;96(1):272-7. Erratum in: Proc Natl Acad Sci U S A 1999 May 11;96(10):5890.

Mai J, Wang H, Yang XF. Th 17 cells interplay with Foxp3+ Tregs in regulation of inflammation and autoimmunity. Front Biosci. 2010 Jun 1;15:986-1006.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Darryl C. Zeldin, M.D.
National Institute of Environmental Health Sciences (NIEHS)
RTP 101 DAVID P RALL BUILDING BG RM A214
111 TW ALEXANDER DR
DURHAM NC 27709
(984) 287-3641
zeldin@niehs.nih.gov

Lisa B. Barber, MEd
National Institute of Environmental Health Sciences (NIEHS)
Building 109 - Modular Clinic, 121
111 T W Alexander Dr
Research Triangle Prk, NC, 27709
(984) 287-4410
barberlm@mail.nih.gov

Lisa B. Barber, MEd
Building 109 - Modular Clinic, 121
111 T W Alexander Dr
Research Triangle Prk, NC, 27709
(984) 287-4410
barberlm@mail.nih.gov

Clinical Trials Number:

NCT01678222

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