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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study
Overview
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.
Primary outcome measures
- Primary endpoints [Time frame: Samples taken at Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- Royal Cornwall Hospital — Truro
Identifiers
NCT: NCT06849284 · 2425.RCHT.12