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.

Launched by ROYAL CORNWALL HOSPITALS TRUST · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a test called the Idylla™ ThyroidPrint® Assay, which helps doctors understand whether certain thyroid nodules are cancerous or not. Thyroid nodules are lumps on the thyroid gland, and sometimes doctors cannot tell if they are dangerous just by looking at them under a microscope. This trial aims to gather more information about how well this test works when used with samples from patients across different hospitals.

To be eligible for this trial, participants need to be adults with a thyroid nodule that is at least 1.0 cm in size and has unclear results from earlier tests. They also need to be scheduled for surgery to remove the nodule. Participants will provide samples that will be tested using the Idylla™ ThyroidPrint® Assay. It’s important to note that some patients may not qualify if their test samples do not meet specific guidelines or if they have signs of cancer spread to nearby lymph nodes. This trial is currently looking for participants, and their involvement could help improve how doctors diagnose and treat thyroid nodules in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Thyroid nodule ≥1.0 cm
• • With indeterminate cytology
• • Surgery due to be performed
• Exclusion Criteria:
• • Specimens which fail to meet the inclusion criteria.
• • FNA fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions.
• • RNA extracts.
• • Patients with ultrasound evidence of malignant cervical adenopathy