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Recruiting NCT06133374

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

Trial Parameters

Condition Papillary Thyroid Cancer
Sponsor University of Calgary
Study Type OBSERVATIONAL
Phase N/A
Enrollment 130
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-01
Completion 2028-05-30

Brief 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 Criteria

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

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