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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06849284
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