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RecruitingNCT06849284Updated Jun 4, 2025

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.

An observational study in Thyroid Cancer, sponsored by Royal Cornwall Hospitals Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Royal Cornwall Hospitals Trust · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid Cancer

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03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 100 is below the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Royal Cornwall Hospitals Trust is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Thyroid nodule ≥1.0 cm
  • With indeterminate cytology
  • Surgery due to be performed

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Primary endpoints

    to measure the accuracy of the Thyroid print test against the surgical pathology report.

    Time frame: Samples taken at Baseline

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06849284
Lead sponsor
Royal Cornwall Hospitals Trust
Responsible party
Sponsor
First posted
Feb 27, 2025
Start date
Dec 16, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jun 4, 2025

Study contacts

Verity Teague Research Sponsorship Facilitator
Contact
rcht.sponsor@nhs.net
0044 1872256429

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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