Thyroid CancerNCT06849284
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 of Thyroid Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is defined as cases where the thyroid nodule has been reported as indeterminate.
Who may be able to join
- Thyroid nodule ≥1.0 cm
- With indeterminate cytology
- Surgery due to be performed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Cornwall Hospital
Truro, Cornwall, TR1 3HD
Verity Teague, 01872256429, rcht.sponsor@nhs.net
About this study
Official title: 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.
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.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints
to measure the accuracy of the Thyroid print test against the surgical pathology report.
Measured: Samples taken at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start16 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849284
- Sponsor's protocol ID
- 2425.RCHT.12
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study
- ClinicalTrials.gov ID
- NCT06849284
- Acronym / sponsor ID
- 2425.RCHT.12
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is defined as cases where the thyroid nodule has been reported as indeterminate.
Key inclusion criteria (3 listed)
- Thyroid nodule ≥1.0 cm
- With indeterminate cytology
- Surgery due to be performed
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoints
Time frame: Samples taken at Baseline
to measure the accuracy of the Thyroid print test against the surgical pathology report.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Verity Teague Research Sponsorship Facilitator (0044 1872256429, rcht.sponsor@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints (time frame: Samples taken at Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.