Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples

What this study is about

The purpose of this study is to determine whether results from a fine needle biopsy are the same as results from a larger sample that is acquired from the surgical pathology using the Thyroid GuidePx® test in patients with papillary thyroid carcinoma.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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 this trial is running

• Foothills Medical Centre, Calgary, Alberta, Canada

Who to contact

Elleine Allapitan · 403-220-8440 · elleine.allapitan@ucalgary.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06133374.