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.
Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2024
CompletedFirst Submitted
Initial submission to the registry
December 18, 2024
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 4, 2025
December 1, 2024
7 months
December 18, 2024
May 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary endpoints
to measure the accuracy of the Thyroid print test against the surgical pathology report.
Samples taken at Baseline
Eligibility Criteria
The study population is defined as cases where the thyroid nodule has been reported as indeterminate.
You may qualify if:
- Thyroid nodule ≥1.0 cm
- With indeterminate cytology
- Surgery due to be performed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Cornwall Hospital
Truro, Cornwall, TR1 3HD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2024
First Posted
February 27, 2025
Study Start
December 16, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
June 4, 2025
Record last verified: 2024-12