All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients

The IoN study is investigating if radioactive iodine treatment, a common therapy after surgery, is truly necessary for all patients with a low-risk type of thyroid cancer. Currently, many patients receive this treatment, but researchers want to see if some can avoid it without affecting their long-term health. The study compares two groups: one receiving radioactive iodine and another not receiving it. The main goal is to find out if patients who skip the treatment fare just as well over five years, meaning their cancer doesn't return or spread. This could potentially reduce side effects and hospital visits for many patients in the future, improving their quality of life.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
University College, London
Enrolment target
504
Start
26 Jun 2012
Estimated completion
01 Mar 2031

What is this study about?

The IoN study is a really important research project looking into how we treat a common type of thyroid cancer. When you have surgery for thyroid cancer, doctors sometimes recommend a follow-up treatment called radioactive iodine. This treatment aims to destroy any tiny cancer cells that might have been left behind after the operation.

However, for some people with a low-risk type of thyroid cancer, it's not entirely clear if this radioactive iodine treatment is always needed. This study wants to find out if patients with low-risk thyroid cancer do just as well without having this treatment. If they do, it could mean that many people could avoid extra treatment, which comes with its own set of effects and hospital visits.

The study is divided into two main parts. First, researchers are checking if it's practical to run a larger study. Then, the main part of the study will compare a group of patients who receive radioactive iodine with a group who don't. The aim is to see if your cancer is less likely to come back or spread after five years, whether you have the treatment or not.

Key takeaways

  • The study investigates radioactive iodine for low-risk thyroid cancer.
  • It compares receiving treatment vs. not receiving it post-surgery.
  • Aims to see if patients do just as well without radioactive iodine.
  • Could help reduce unnecessary treatments for some patients.
  • Participation involves close monitoring for up to five years.

Who may be eligible?

To be considered for the IoN study, you would need to have been diagnosed with a specific type of thyroid cancer called *differentiated thyroid cancer*. This diagnosis would have been confirmed by a specialist team of doctors using tissue samples from your surgery. Importantly, your cancer must be considered 'low risk' by your doctors, even if it has certain features like being a particular size or having spread to very small nearby lymph nodes in the neck.

You would also need to have had all your thyroid gland removed by surgery within the last six months, with no obvious cancer left behind. Generally, participants need to be 16 years old or older and in reasonably good health, able to look after themselves. If you are a woman who could become pregnant, you would also need a negative pregnancy test to make sure it's safe for you.

The specific details about your cancer are important, including its size and type, but your specialist team would assess all of this carefully to decide if you are a good fit for the study. They would also need to be able to review your cancer tissue in more detail.

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. Have you been diagnosed with a type of thyroid cancer called 'differentiated thyroid cancer'?
  2. Has your specialist healthcare team agreed that your cancer is considered 'low-risk'?
  3. Have you had all your thyroid gland removed by surgery within the last six months, with no obvious cancer left?
  4. Are you 16 years or older and generally able to care for yourself?
  5. If you are a woman who could become pregnant, are you able to have a negative pregnancy test?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the IoN study, you would be randomly assigned to one of two groups: either you would receive the standard radioactive iodine treatment, or you would not receive it. The choice of group is made by chance, like flipping a coin.

If you are in the radioactive iodine group, you would receive the treatment and follow standard hospital procedures for this. If you are a woman, you would need to use contraception during the trial and for six months after your treatment. Men would need to use contraception for four months after treatment.

Throughout the study, regardless of which group you're in, you will have regular check-ups and tests, similar to what you would have for your usual follow-up care for thyroid cancer. The researchers will be closely monitoring your health over five years to see how you are doing. The total duration of your participation in the main part of the study would be five years.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that if you are in the group that doesn't receive radioactive iodine, you might avoid the side effects and practical difficulties associated with that treatment, without negatively impacting your long-term health. However, there's also the chance that not receiving the treatment could be less effective for you personally. If you receive radioactive iodine, you will experience the known side effects of that treatment. The study is carefully designed to monitor your health closely. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Belfast Health and Social Care Trust
    Verified postcode
    Belfast, United Kingdom
  • University Hospitals Birmingham NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom
  • University Hospitals Sussex NHS Foundation Trust
    Verified postcode
    Brighton, United Kingdom
  • University Hospital Bristol NHS Foundation Trust
    Verified postcode
    Bristol, United Kingdom
  • Cambridge University Hospitals NHS Foundation Trust
    Verified postcode
    Cambridge, United Kingdom
  • East Kent Hospitals University NHS Foundation Trust
    Verified postcode
    Canterbury, United Kingdom
  • Velindre NHS Trust
    Verified postcode
    Cardiff, United Kingdom
  • Mid and South Essex NHS Foundation Trust
    Verified postcode
    Chelmsford, United Kingdom
  • Gloucestershire Hospitals NHS Trust
    Verified postcode
    Cheltenham, United Kingdom
  • Royal Derby Hospital NHS Foundation Trust
    Verified postcode
    Derby, United Kingdom
  • NHS Lothian
    Verified postcode
    Edinburgh, United Kingdom
  • Royal Devon and Exeter Hospital NHS Foundation Trust
    Verified postcode
    Exeter, United Kingdom

Common questions

What is 'low-risk' thyroid cancer?

Low-risk means your doctors believe your specific thyroid cancer is less likely to spread or come back after surgery, based on its type and how it looked under the microscope.

What is radioactive iodine treatment?

It's a treatment where you take a small dose of iodine that has been made radioactive. Cancer cells that are left after surgery take up this iodine, and the radiation helps to destroy them.

Why is this study important?

This study could help doctors understand if some patients can safely avoid radioactive iodine treatment after surgery, potentially reducing unpleasant side effects and improving quality of life.

Will I still have regular check-ups if I don't get the treatment?

Yes, regardless of which group you are in, you will have regular medical check-ups and tests to closely monitor your health and ensure any changes are noticed quickly.

Can I choose which group I'm in (with or without treatment)?

No, participants are randomly assigned to a group. This helps ensure the study results are fair and reliable, preventing bias.

How to find out more

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

Discussion

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