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RecruitingOBSERVATIONAL

Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

This research study is trying to understand more about Chronic Granulomatous Disease (CGD). Doctors are looking at blood samples from both children and adults who have CGD. They want to measure certain infection-fighting proteins called 'antibodies' and also 'cytokines', which are substances that play a role in inflammation in the body. By doing this, they hope to find out how common these markers are in people with CGD. This information could help doctors understand the condition better and potentially lead to improved ways of caring for patients. It's an observational study, meaning participants won't receive new treatments, but their existing health markers will be studied.

At a glance

Status
Recruiting
Sponsor
Ensoma
Enrolment target
60
Start
18 Nov 2024
Estimated completion
01 Jun 2026

What is this study about?

This study is all about understanding more about a condition called Chronic Granulomatous Disease, or CGD for short. People with CGD have a problem with their immune system, which makes it harder for their bodies to fight off certain infections.

In this research, doctors are taking blood samples from people of all ages who have CGD. They are specifically looking for two things in the blood: 'antibodies' and 'cytokines'. Antibodies are like little soldiers in your immune system that help fight off germs. Cytokines are substances that send messages between cells and can be involved in inflammation, which is your body's response to injury or infection.

The main goal is to find out how often certain antibodies (specifically those that fight a virus called adenovirus) and cytokines are present in people with CGD. By collecting this information, researchers hope to get a clearer picture of how the immune system works, or doesn't work, in people with CGD. This deeper understanding could be very helpful for doctors in the future, as it might lead to better ways to manage the condition and support those living with it.

Key takeaways

  • This study helps understand Chronic Granulomatous Disease (CGD) better.
  • It involves giving blood samples to check for certain immune system markers.
  • Both children and adults with CGD can take part.
  • It's an observational study, so no new treatments are given.
  • Your participation could help improve future care for people with CGD.

Who may be eligible?

To take part in this study, you must have a confirmed diagnosis of Chronic Granulomatous Disease (CGD). This diagnosis must have been made by your doctor based on specific test results that show how your immune cells are working, or through a genetic test confirming a problem with a specific gene linked to CGD.

It's important that you (or your parent or guardian if you're a child) are able to understand what the study involves and agree to take part by signing a consent form. You also need to be able to follow the study instructions and attend any necessary appointments to provide samples.

You cannot take part if you have had a bone marrow transplant from another person or if you have previously received an experimental gene therapy. Also, if the study doctor thinks you wouldn't be able to provide the blood samples needed, you wouldn't be able to join.

Quick self-check
  • Do you have a confirmed diagnosis of CGD from your doctor?
  • Are you (or your child) able to understand and sign consent forms?
  • Have you NOT had a bone marrow transplant from another person?
  • Have you NOT had an experimental gene therapy?
  • Are you able to provide blood samples as required?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the main thing you would need to do is provide one or more blood samples. These samples will then be tested to look for the antibodies and cytokines we mentioned. Since this is an observational study, you won't be given any new medications or treatments as part of the research. There are no special visits beyond giving the blood sample, and the study doesn't involve long-term follow-up or multiple appointments after the sample collection. The total time involvement for you would be limited to the collection of the blood samples.

Potential risks and benefits

Potential benefits of taking part include helping researchers learn more about CGD, which could improve care for others in the future. You will not personally receive any new treatments or direct health benefits from participating in this study. The main risk involves giving blood samples, which can sometimes cause minor bruising or discomfort. Serious problems from blood draws are very rare. Remember, taking part in any study is completely voluntary, and you are free to change your mind and withdraw at any time without affecting your medical care.

Locations (52)

  • Home-based telemedicine
    Montgomery, United States· Recruiting
  • Home-based telemedicine
    Phoenix, United States· Recruiting
  • Home-based telemedicine
    Little Rock, United States· Recruiting
  • Home-based telemedicine
    Sacramento, United States· Recruiting
  • University of California, San Francisco
    San Francisco, United States· Recruiting
  • Home-based telemedicine
    Denver, United States· Recruiting
  • Home-based telemedicine
    Hartford, United States· Recruiting
  • Home-based telemedicine
    Dover, United States· Recruiting
  • Home-based telemedicine
    Washington D.C., United States· Recruiting
  • Home-based telemedicine
    Tallahassee, United States· Recruiting
  • Home-based telemedicine
    Atlanta, United States· Recruiting
  • Home-based telemedicine
    Boise, United States· Recruiting

+40 more sites — see the official record for the full list.

Common questions

What is Chronic Granulomatous Disease (CGD)?

CGD is a rare genetic condition where your immune system struggles to fight off certain types of infections.

Will I receive any new treatment if I join this study?

No, this is an observational study, meaning you won't receive any new medications or treatments.

What will I have to do if I take part?

You'll be asked to provide one or more blood samples for researchers to analyse.

Who can join this study?

Adults and children with a confirmed diagnosis of CGD who meet specific health criteria can join.

Are there any risks to taking part?

The main risk is minor discomfort or bruising from blood draws, which is generally very safe.

How to find out more

Andrew Dietz, MD, MSCR

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Prevalence of Antibodies and Cytokines in Participants With …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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