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.

May 29, 2025 updated by: Royal Cornwall Hospitals Trust

Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Verity Teague Research Sponsorship Facilitator
  • Phone Number: 0044 1872256429
  • Email: rcht.sponsor@nhs.net

Study Locations

  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3HD
        • Recruiting
        • Royal Cornwall Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoints
Time Frame: Samples taken at Baseline
to measure the accuracy of the Thyroid print test against the surgical pathology report.
Samples taken at Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Cornwall Hospitals Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2425.RCHT.12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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