RecruitingNCT06849284

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.

Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study


Sponsor

Royal Cornwall Hospitals Trust

Enrollment

100 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the performance of a molecular test called the Idylla ThyroidPrint Assay, which analyzes a small sample taken from a thyroid nodule (lump in the thyroid) to help doctors determine whether the nodule is cancerous — particularly when the standard cytology result comes back 'indeterminate' (unclear). **You may be eligible if...** - You have a thyroid nodule that is at least 1.0 cm in size - The initial biopsy (fine needle aspiration) returned an indeterminate (unclear) result - You are scheduled for surgery to remove the nodule **You may NOT be eligible if...** - Your biopsy result was clearly benign or clearly malignant - Your thyroid nodule is smaller than 1.0 cm - Your biopsy sample was preserved in formalin or alcohol (incompatible with the test) - Imaging shows suspicious lymph nodes in the neck suggesting cancer has spread - Your sample consists only of RNA extracts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

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NCT06849284


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