Comparing biopsy results to surgical samples in thyroid cancer
Official title: Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples
Run by University of Calgary · NCT06133374 · Data updated 2026-11-12
This study is testing if the results from small needle biopsies of thyroid cancer match up with those from larger surgical samples to help doctors make better treatment decisions for patients with papillary thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | May 30, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT06133374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a diagnosis of papillary thyroid cancer based on specific biopsy results.
✕Probably not a fit
Patients with a history of neck radiation or those unable to undergo a fine needle biopsy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate whether the molecular classification of papillary thyroid cancer obtained from fine needle biopsies (FNB) aligns with results from surgical samples using the Thyroid GuidePx® test. By analyzing the molecular features of tumors, the study seeks to provide critical information that could guide surgical decisions before the actual surgery takes place. The research focuses on patients diagnosed with papillary thyroid carcinoma, particularly those with specific cytological classifications. The goal is to determine if FNB can reliably inform treatment strategies and improve patient outcomes.
Why it matters
Potential benefit: If successful, this study could enable more personalized surgical approaches for patients with papillary thyroid cancer, potentially reducing unnecessary surgeries.
How similar studies have gone: Previous feasibility studies have shown promise in using fine needle biopsies for molecular characterization, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * A diagnosis of papillary thyroid cancer based on a fine needle biopsy (FNB) interpreted as a Bethesda V or VI cytology * A diagnosis of Atypia of Undetermined Significance (AUS) or Follicular Lesion of Undetermined Significance (FLUS) interpreted as Bethesda III or IV cytology (indeterminate nodule) ThyroSpec positive for BRAFV600E, TERT, rearrangements in BRAF, RET, NTRK1, NTRK3, RAS + TERT, RAS + EIF1AX, AKT1, PI3CA, CTNNB1, EGFR, rearrangements in ALK * Tumor size \> 1 cm in maximal diameter on imaging prior to surgery * The patient is an operative candidate * The patient has provided consent Exclusion Criteria: * History of radiation to the neck for situations such as medical radiation, radiation exposure in a work environment (nuclear power plant/reactor), or radiation exposure through release of radioactive materials into the nearby environment from a nuclear power plant/reactor. * Unable or unwilling to have a fine needle biopsy * Unwilling to undergo thyroidectomy * Final pathology does not demonstrate papillary thyroid cancer * Cases where there is no clear dominant nodule * Cases where there are multiple nodules that preclude sampling of a defined nodule
Where it's running
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Foothills Medical Centre
Calgary, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Caitlin Yeo, MD — Alberta Health services
- Study coordinator: Elleine Allapitan
- Email: elleine.allapitan@ucalgary.ca
- Phone: 403-220-8440
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing whether ultrasound-guided thermal ablation can safely and effectively treat small papillary thyroid cancers in patients with less aggressive disease over a follow-up period of at least a year.
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Analyzing genetic mutations in papillary thyroid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.