TEST:

Thyroid GuidePx®

Integrating transcriptomic data into clinical decision-making enables more precise selection for treatment escalation or de-escalation. To unlock the full potential of transcriptome-guided management in PTC, prospective validation and adoption into ATA and NCCN guidelines will be critical.

Transcriptomic-based prognostic tests, like the novel Thyroid GuidePx® classifier, effectively stratify PTCs into distinct molecular subgroups with differing recurrence risks, surpassing traditional clinicopathological models in predictive accuracy. By shifting toward biologically informed decision-making, we can enhance clinical efficiency, minimize patient morbidity, and improve overall healthcare resource utilization.

P=N/A; Not yet recruiting --> Recruiting

Thyroid GuidePx reliably identifies a low-risk subgroup (early type 1 and early type 2 papillary thyroid cancers) for which conservative procedures would be appropriate. Tall cell variants in this subgroup are uncommon (1.2%), and none of the tall cell variants in this subgroup recurred. Type 3 papillary thyroid cancers have greater recurrence rates in both early and advanced papillary thyroid cancers. Tall cell variant appears to further increase recurrence in this subgroup.

While recurrence data were not available for this series of radiation-induced PTCs, Type 3 and advanced Type 1/2 cancers defined by Thyroid GuidePx® had more aggressive clinical features, including a higher rate of RET fusions, a surrogate marker for recurrence risk in radiation-induced PTC.

P=N/A; Initiation date: Dec 2023 --> Jun 2024

P=N/A; N=130; Not yet recruiting; Sponsor:University of Calgary

P=N/A; N=130; Not yet recruiting; Sponsor:University of Calgary

"Dr. Oliver Bathe presented results from a study of 742 patients at the 2022 Annual Meeting of the American Thyroid Association. The study demonstrated that Thyroid GuidePx® has a 97% specificity in identifying patients with low-risk papillary thyroid cancer. This is much more accurate than the 80% specificity the conventional ATA risk stratification system identifies."

The 5‐year recurrence rate for early Type 1 PTC (enriched with Ras‐like follicular variants) was significantly lower in early PTC in comparison to advanced PTC (3.7% vs. 12%). Similarly, early Type 2 PTC had a much lower recurrence rate in comparison to advanced cancers (1.2% vs.

Thyroid GuidePx was capable of yielding repeatable gene expression measures. A classification algorithm customized for FFPE enabled reliable and repeatable classification of molecular subtypes.