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RecruitingNAINTERVENTIONAL

Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers

This study, called a clinical trial, is investigating the best way to treat a type of cancer called low-risk differentiated thyroid cancer. Doctors want to find out if removing only half of the thyroid gland (called hemithyroidectomy) is just as good, safe, and cost-effective as removing the whole thyroid gland (total thyroidectomy). They will look at two groups of patients. One group has already had half their thyroid removed and then found out they have low-risk cancer. The other group is newly diagnosed and hasn't had surgery yet. Patients will be randomly placed into different treatment groups and followed up for six years to see which approach works best.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University College, London
Enrolment target
456
Start
14 Feb 2022
Estimated completion
31 Jul 2031

What is this study about?

Imagine you've been told you have a type of cancer in your thyroid gland, which is a small gland in your neck. This particular type is called 'low-risk differentiated thyroid cancer.' This study is trying to answer an important question for people like you: is it better to remove just the part of the thyroid with cancer, or the whole thyroid gland? Both options have different impacts on your body and your life, and doctors want to understand which one is generally better for low-risk cases.

The study will involve two main groups of patients. In the first group, some people have already had part of their thyroid removed for various reasons, and then doctors discovered that the removed part contained low-risk thyroid cancer. For these individuals, the study will help decide if they need a second operation to remove the rest of their thyroid, or if simply keeping an eye on things (called surveillance) is enough. In the second group, patients are newly diagnosed with low-risk thyroid cancer and haven't had surgery yet. The study will randomly assign them to either have half their thyroid removed or the whole thyroid removed from the start.

The main goal of this research is to see if removing only half the thyroid (hemithyroidectomy) is a safe and effective treatment that also uses healthcare resources wisely, compared to removing the entire thyroid (total thyroidectomy). Doctors will be looking at how well patients do over six years after their surgery. This research is important because it could help doctors make better decisions about treatment for future patients with low-risk thyroid cancer, potentially leading to less invasive surgery when appropriate.

Key takeaways

  • The study explores two surgical options for low-risk thyroid cancer: removing half (hemithyroidectomy) or all (total thyroidectomy) of the thyroid.
  • It aims to see if less invasive surgery is as good and cost-effective as more extensive surgery.
  • Patients will be randomly assigned to different treatment groups.
  • The study will follow participants for six years to track their health and outcomes.
  • It will help doctors decide the best treatment for specific low-risk thyroid cancers in the future.

Who may be eligible?

To be considered for this study, you need to be at least 16 years old. Your doctors must have diagnosed you with a specific type of low-risk thyroid cancer, like papillary thyroid cancer or follicular thyroid cancer. Importantly, the cancer must be small (generally 4cm or less) and contained mostly within the thyroid gland, or have spread only minimally.

There are certain situations that would mean you couldn't join the study. For example, if your thyroid cancer is larger than 4cm, or if it's a more aggressive or fast-growing type, like anaplastic or medullary thyroid cancer, you wouldn't be eligible. Also, if the cancer has spread widely to other parts of your body, or if it's a very specific non-invasive type called NIFTP, you wouldn't be able to participate. The study is specifically for low-risk cases, so anything that makes your cancer higher risk would prevent you from joining.

Your medical team, including a group of specialists, would carefully review your medical history and test results to see if the study is a good fit for you. They will look at detailed information about your cancer, such as its size, how it looks under a microscope, and if it has spread to nearby lymph nodes, to make sure you meet all the specific criteria for being considered low-risk.

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. Are you aged 16 or older?
  2. Have you been diagnosed with low-risk papillary or follicular thyroid cancer?
  3. Is your cancer generally 4cm or smaller and mostly contained within your thyroid?
  4. Is your cancer *not* an aggressive or widely spread type?
  5. Has your medical team confirmed your cancer is considered 'low-risk'?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement will depend on which group you're in. If you've already had half your thyroid removed, you'll either have regular check-ups (surveillance) or another operation to remove the rest of your thyroid. If you haven't had surgery yet, you'll either have an operation to remove half your thyroid or an operation to remove the whole thyroid.

All participants will have regular visits after their surgery for follow-up. These check-ups will usually involve a review with your doctor and may include some tests to monitor your health and the cancer. These follow-up appointments will happen annually for six years after your surgery. There are no specific medications given as part of the study; it's focused on the surgical approach.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of less extensive surgery if you're in the group receiving a hemithyroidectomy, which might mean a quicker recovery and fewer side effects associated with removing the entire thyroid. You would also be contributing to medical knowledge that could help future patients. However, there are potential risks with any surgery, such as bleeding, infection, or damage to nearby structures. Choosing to have less of the thyroid removed may also carry a small, unknown risk that the cancer could return, which is what the study is trying to evaluate. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (33)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Leighton Hospital
    Verified postcode
    Crewe, United Kingdom· Recruiting
  • Royal United Hospital
    Verified postcode
    Bath, United Kingdom· Not yet recruiting
  • Queen Elizabeth Hospital
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Verified postcode
    Bristol, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • University Hospital of Wales
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Colchester Hospital
    Verified postcode
    Colchester, United Kingdom· Recruiting
  • Royal Derby Hospital
    Verified postcode
    Derby, United Kingdom· Recruiting
  • Ninewells Hospital
    Verified postcode
    Dundee, United Kingdom· Recruiting
  • NHS Lothian
    Verified postcode
    Edinburgh, United Kingdom· Recruiting
  • Royal Devon and Exeter Hospital
    Verified postcode
    Exeter, United Kingdom· Recruiting
  • Forth Valley Royal Hospital
    Verified postcode
    Falkirk, United Kingdom· Recruiting

Common questions

What is 'low-risk differentiated thyroid cancer'?

This is a common type of thyroid cancer that usually grows slowly and is less likely to spread. It's often found early and has a good outlook.

What's the difference between 'hemithyroidectomy' and 'total thyroidectomy'?

A hemithyroidectomy is an operation to remove half of your thyroid gland. A total thyroidectomy is an operation to remove the entire thyroid gland.

Why is this study being done?

Doctors want to find out if removing only half of the thyroid gland is just as safe and effective as removing the whole gland for certain low-risk thyroid cancers, potentially making treatment less invasive.

Will I get to choose which surgery I have?

No, if you join this study, you will be randomly assigned to one of the surgical approaches or to surveillance, by chance, like flipping a coin. This helps make the study fair.

How long will I be involved in the study?

After your surgery, you will be followed up typically once a year for six years to monitor your health and the results of your treatment.

How to find out more

Jeannie Chamberlain

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 "Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyro…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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