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.
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
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
Patients with a preoperative tissue diagnosis of PTC (Bethesda VI) or suspicious for PTC (Bethesda V) or a tissue diagnosis 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, eligible for partial or total thyroidectomy
Cohort
Prospective
Not listed
Concordance between Thyroid GuidePx® molecular classifications acquired from FNAs and matched frozen surgical samples
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.
The technical success rate in completing a valid Thyroid GuidePx® using FNB and FFPE surgical samples
Sufficient RNA of good quality to perform the test
The recurrence outcomes using the ATA risk stratification system vs. patients classified by Thyroid GuidePx® using surgical samples
Biochemical and structural recurrence
The test performance of Thyroid GuidePx® as a prognostic test (FNB and surgical samples) in comparison to ATA Risk Stratification.
Specificity, sensitivity, AUROC, positive predictive value, and negative predictive value,
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University of Calgary
Lead sponsor
Qualisure Diagnostics Inc.
Collaborator
Alberta Health services
Collaborator
