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Clinical Trials in Canada / NCT06133374
Recruiting Observational

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

NCT06133374 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2024-07-01
Last updated
2026-01-15

Condition(s) studied

Papillary Thyroid Cancer

Study summary

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)

Trial sites (1)

FacilityCityRegionStatus
Foothills Medical Centre Calgary Alberta Recruiting

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Other trials for the same condition

Official registry record

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.

View NCT06133374 on ClinicalTrials.gov ↗ ← All trials in Canada