All studies
CompletedObservational

Does persistent inflammation present in the thyroid gland and affect the quality of life after radioiodine therapy in Graves’ disease?

This study is investigating why some people with Graves' disease treated with radioiodine therapy might have a poorer quality of life years later, compared to those treated with surgery. It's thought that ongoing inflammation (swelling) in the thyroid gland might be the cause, even after radioiodine treatment. We'll be looking at blood tests, questionnaires, and special scans to see if there's a link between this inflammation and how people feel. The results will help us understand how to improve long-term well-being for patients having radioiodine therapy. Participants will have three visits over a year and some will have two special scans.

At a glance

Status
Completed
Sponsor
Newcastle upon Tyne Hospitals NHS Foundation Trust
Enrolment target
30
Start
08 Oct 2024
Estimated completion
01 Jun 2026

What is this study about?

You might be familiar with Graves' disease, an illness where your immune system mistakenly attacks your thyroid gland, making it overactive. One common treatment for Graves' disease is called radioiodine therapy, which is often very effective. However, some studies have shown that a few years after this treatment, some patients report feeling less well overall compared to those who had surgery. Doctors aren't entirely sure why this happens.

This study aims to find out if ongoing inflammation (swelling) in the thyroid gland, even after radioiodine treatment, could be the reason for feeling unwell. When you have Graves' disease, your immune system makes certain proteins called 'autoantibodies'. While these usually disappear after surgery, they can sometimes stay in the blood for years after radioiodine therapy. We want to see if these persistent immune system markers are linked to a poorer quality of life.

By taking part, you would help us better understand the long-term effects of radioiodine therapy. This knowledge is important because it could lead to new ways of making sure everyone treated for Graves' disease feels as good as possible in the years that follow. We hope to find clues that will guide future research into improving care.

Key takeaways

  • This study explores why some Graves' disease patients feel unwell years after radioiodine.
  • It investigates if ongoing thyroid inflammation is the cause.
  • Participation involves three clinic visits over a year, blood tests, and questionnaires.
  • Some participants will also have two special PET scans.
  • Results will help improve future care for Graves' disease patients.
  • There are no direct personal benefits but participation helps future understanding.

Who may be eligible?

This study is for adults generally aged between 16 and 100 years old. You could take part if you have Graves' disease and are about to have either radioiodine therapy or thyroid surgery for your condition. It's important that you are able to understand the study and agree to take part in writing.

However, you won't be able to join if you are currently taking medicines that affect your immune system, or if you have other long-term inflammatory or autoimmune conditions like inflammatory bowel disease or certain rheumatological problems. This is to make sure the study focuses specifically on Graves' disease and its treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have Graves' disease confirmed by a doctor?
  2. Are you planning to have radioiodine therapy or thyroid surgery for your Graves' disease?
  3. Are you aged between 16 and 100 years old?
  4. Are you able to provide written consent to join the study?
  5. Are you NOT taking medicines that affect your immune system (like immunosuppressants)?
  6. Do you NOT have other long-term inflammatory or autoimmune conditions?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will involve three visits to the clinic in total: one at the beginning, one after 6 months, and a final one after 12 months. During these visits, we will take blood samples to check for specific immune markers and signs of inflammation. You will also be asked to complete two sets of questionnaires about your quality of life – basically, how you are feeling and how your health impacts your daily life.

About half of the patients who have radioiodine therapy will also have two special scans called PET scans. These scans will happen at the start of the study and again after 12 months. These scans help us look closely at your thyroid gland for any signs of inflammation. There are no changes to your usual medical treatment for your Graves' disease as part of this study.

Potential risks and benefits

There are no direct personal benefits for you by taking part in this study. However, the information we gather will be very valuable in helping doctors understand more about Graves' disease and radioiodine therapy, potentially leading to better care for future patients. There are some small risks to consider. Some participants will have PET scans, which involve a very small amount of radiation. While everyone has a natural risk of developing cancer, taking part might slightly increase this overall lifetime risk from about 50% to about 50.16%. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    City only
    Newcastle upon Tyne, England

Common questions

What is Graves' disease?

Graves' disease is an illness where your immune system causes your thyroid gland to be overactive, producing too many thyroid hormones.

What is radioiodine therapy?

It's a treatment for Graves' disease that uses a small amount of radioactive iodine to calm down the overactive thyroid gland.

What does 'quality of life' mean in this study?

It refers to how your health affects your overall well-being, including how you feel physically and mentally, and your ability to do daily activities.

Will my regular medical care be affected if I join?

No, your standard medical care for Graves' disease will continue as usual and will not be changed by taking part in this study.

Where does the study take place?

The study is being run from a special clinic for thyroid conditions at the Newcastle upon Tyne Hospitals NHS Foundation Trust in the UK.

How to find out more

Earn Gan

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

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