Evaluating the Idylla ThyroidPrint Assay for Indeterminate Thyroid Nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the performance of the Idylla™ ThyroidPrint® Assay in predicting the nature of indeterminate thyroid nodules using clinical samples. It is a multicenter, prospective study that matches the assay results to the gold standard of surgical pathology. The primary focus is to calculate the sensitivity, specificity, and predictive values of the assay, while also evaluating its failure rate and the nature of any false results.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Cornwall Hospital
  Truro, Cornwall, United Kingdom Recruiting

Study contacts

• Study coordinator: Verity Teague Research Sponsorship Facilitator
• Email: rcht.sponsor@nhs.net
• Phone: 0044 1872256429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.