At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 6 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2024-12-16
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for thyroid cancer
- • Clinical study - 100 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with thyroid cancer
Where?
- • Truro - Royal Cornwall Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Thyroid nodule ≥1.0 cm
- ✓With indeterminate cytology
- ✓Surgery due to be performed
Who cannot take part
- ✗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...
- ✗RNA extracts.
- ✗Patients with ultrasound evidence of malignant cervical adenopathy
See the full criteria
Where Is This Study? (1 UK site)
Royal Cornwall Hospital
Truro TR1 3HD, United Kingdom
How to Get in Touch
Verity Teague Research Sponsorship Facilitator
Sponsor contactCONTACT