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.

Royal Cornwall Hospitals Trust

Status: Enrolling

Conditions: Thyroid Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06849284

2425.RCHT.12

Details and patient eligibility

About

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.

Full description

This is a multicenter, non-interventional (observational), prospective, post-market study, matching the Idylla™ ThyroidPrint® RUO Assay result to the gold standard of surgical pathology.

The study population is defined as cases where the thyroid nodule has been reported as indeterminate.

Primary endpoints are the calculation of the sensitivity, specificity, and the negative and positive predictive values of the Idylla™ ThyroidPrint® RUO Assay for indeterminate thyroid nodules.

Secondary endpoint: to assess the failure rate of Idylla™ ThyroidPrint® RUO Assay, including errors and invalids; describe the nature of false negative and false positive cases.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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