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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Concordance between Thyroid GuidePx® molecular classifications acquired from FNAs and matched frozen surgical samples — December 1, 2025 The molecular class assignment (Type 1, Type 2 and Type 3), based on the pattern of expression of prognostic genes, will be compared between samples obtained by FNB and matched frozen surgical specimens. The significance of concordance between the two sample types will be determined using the kappa statistic.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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