Evaluating the Idylla ThyroidPrint Assay for Indeterminate Thyroid Nodules
Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study
Royal Cornwall Hospitals Trust · NCT06849284
This study is testing if the Idylla ThyroidPrint Assay can help doctors better understand indeterminate thyroid nodules by comparing its results to those from surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Cornwall Hospitals Trust (other) |
| Locations | 1 site (Truro, Cornwall) |
| Trial ID | NCT06849284 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with thyroid nodules that are 1.0 cm or larger and have been classified as indeterminate based on cytology.
Not a fit: Patients with thyroid nodules that do not meet the inclusion criteria or those with evidence of malignant cervical adenopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy for patients with indeterminate thyroid nodules, potentially leading to better treatment decisions.
How similar studies have performed: Other studies have explored similar diagnostic assays for thyroid nodules, but the specific performance of the Idylla ThyroidPrint Assay in this context is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Truro, Cornwall
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Cancer