RecruitingOBSERVATIONAL

To Perform a Post-market Study of the Performance of the Idylla ThyroidPrint Assay Using Clinical Samples in Predicting the Nature of Indeterminate Thyroid Nodules (ITNs) Across Multiple Centers.

This study investigates a new laboratory test called Idylla ThyroidPrint. It's designed for people who have a thyroid lump (nodule) where initial tests couldn't definitively say whether it was harmless or cancerous – doctors call these 'indeterminate' nodules. The main goal is to see how accurate this new test is at predicting if a lump is benign (not cancer) or malignant (cancerous), by comparing its results to the final diagnosis after surgery. The study will look at various aspects of the test's performance, like how often it's correct and if there are any issues with using it. This will help doctors understand if the Idylla ThyroidPrint test could be a useful tool in deciding the best next steps for patients with these uncertain thyroid lumps.

At a glance

Status

Recruiting

Sponsor

Royal Cornwall Hospitals Trust

Enrolment target

100

Start

16 Dec 2024

Estimated completion

30 Jun 2025

Thyroid Cancer

What is this study about?

When you have a lump in your thyroid gland, doctors often do a test called a fine needle aspiration (FNA) to collect some cells. Sometimes, the results of this test aren't clear enough to say for sure if the lump is harmless or if it might be cancer. These uncertain results are called 'indeterminate' thyroid nodules. This often leaves patients feeling worried and doctors needing more information to decide the best path forward.

This study is looking at a new laboratory test called the Idylla ThyroidPrint. It's a non-interventional study, meaning you won't be given any new medications or treatments as part of it. Instead, researchers are simply observing and comparing the results of this new test with the standard diagnosis you would get after having surgery to remove the nodule. The aim is to see how accurate the Idylla ThyroidPrint test is at predicting whether an indeterminate nodule is actually benign (not cancer) or malignant (cancerous).

The information gathered from this study is really important because it could help doctors make more informed decisions about treatment for people with indeterminate thyroid nodules. If the Idylla ThyroidPrint test proves to be very accurate, it might help some patients avoid surgery if their nodule is likely benign, or help others get surgery sooner if it's likely cancerous. Ultimately, this research aims to improve how we diagnose and manage these types of thyroid lumps, potentially leading to better outcomes for patients.

Key takeaways

This study evaluates a new test for 'indeterminate' thyroid lumps.
It aims to improve diagnosis for unclear thyroid biopsy results.
No extra treatments or procedures for participants.
The study uses tissue from your planned surgery.
Results could help future patients avoid unnecessary surgery or get earlier treatment.

Who may be eligible?

To be part of this study, you would need to meet a few specific conditions. Firstly, your thyroid lump must be at least 1 centimetre (about the size of a large pea) and, as mentioned, your previous biopsy results (FNA) must have been unclear or 'indeterminate'. Lastly, you must already be scheduled to have surgery to remove your thyroid lump.

There are also some reasons why you might not be able to join. For example, if your biopsy sample wasn't collected or stored in a very specific way that the study requires, or if you already have signs of cancer spread to lymph nodes in your neck as seen on an ultrasound, you wouldn't be able to participate. This study isn't suitable if your biopsy sample has already been processed into RNA extracts.

This study is open to both men and women aged 18 or older.

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.

Do you have a thyroid lump that is 1cm or larger?
Was your most recent thyroid biopsy result 'indeterminate' (unclear)?
Are you already scheduled to have surgery to remove your thyroid lump?
Do you have signs of cancer in other parts of your neck on ultrasound?

Answer every question to see your result.

What does participation involve?

Taking part in this study is quite straightforward because it's an 'observational' study. This means you won't have any extra appointments, tests, or treatments specifically for the study. The researchers will simply be using the tissue sample from your thyroid lump that was collected during your routine surgery. There's no extra burden on you as a patient once you've agreed to participate beyond your standard medical care. Your participation will involve allowing your medical team to share your tissue sample and its final diagnosis after surgery with the study researchers so they can compare it with the results from the Idylla ThyroidPrint test. There are no follow-up visits or drugs involved that are specific to the study, and your participation effectively ends once the samples and results are analysed.

Potential risks and benefits

There are no direct medical risks from participating in this study as you won't undergo any extra procedures or treatments. The main benefit is that the information from your tissue sample will help improve our understanding of how to best manage indeterminate thyroid nodules, potentially helping future patients. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your standard medical care in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Cornwall Hospital
Verified postcode
Truro, United Kingdom· Recruiting

Common questions

What is an 'indeterminate' thyroid nodule?

It's a thyroid lump where initial tests, like a needle biopsy, couldn't clearly say if it was harmless (benign) or cancerous (malignant).

What is the Idylla ThyroidPrint test?

It's a new lab test being investigated to help predict if an indeterminate thyroid nodule is benign or cancerous, using a sample from the nodule.

Will I have extra tests or appointments for this study?

No, this is an observational study. Researchers will use existing samples from your routine surgery, so no extra tests or visits are needed.

Will I know my Idylla ThyroidPrint test results?

The study aims to evaluate the test, and your doctor can discuss if and how these research results might be shared with you if available and relevant to your care.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any point, without needing to give a reason, and it won't affect your medical care.

How to find out more

Verity Teague Research Sponsorship Facilitator

rcht.sponsor@nhs.net 0044 1872256429 Official trial record

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