Thyroid Cancer
Conditions
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Royal Cornwall Hospitals Trust
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoints | Samples taken at Baseline | to measure the accuracy of the Thyroid print test against the surgical pathology report. |
Countries
United Kingdom
Contacts
Primary ContactVerity Teague Research Sponsorship Facilitator
Outcome results
None listed