The COX-2 Gene and the Immune System (NCT01678222) | Clinical Trial Compass
CompletedNot Applicable
The COX-2 Gene and the Immune System
United States117 participantsStarted 2013-05-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 150 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
* Co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied how specific COX-2 gene variants — called 765G>C and 8473T>C — affect immune cell behavior in people with allergic inflammation or asthma; is it worth finding out if I carry either of these genetic variants, and what would that mean for how my asthma or allergies are managed?
2Since this was a completed research study focused on understanding the biology behind Th2, Th9, and Th17 immune responses, has anything come out of this research that might actually change the treatment options available to me?
3This trial was labeled 'Phase NA,' which suggests it was more of a basic science or observational study rather than a drug trial — does that mean the findings are still a long way from affecting real-world treatment, and should I be looking at other clinical trials that are testing actual therapies?
4Given that this study looked at how COX-2 gene differences might drive the kind of immune inflammation seen in asthma, could my current medications — like corticosteroids or other anti-inflammatory drugs — be working differently for me depending on my genetic makeup?
5Since this trial has already been completed, are there any follow-up studies or newer trials building on these COX-2 gene findings that might be more relevant for someone with my specific type of asthma or allergic condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
Timeframe: Ongoing
2
To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo
Timeframe: Ongoing
Trial details
NCT IDNCT01678222
SponsorNational Institute of Environmental Health Sciences (NIEHS)