RecruitingNCT06133374

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

Sponsor

University of Calgary

Enrollment

130 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Papillary Thyroid Cancer

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria6

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

Locations(1)

Foothills Medical Centre

Calgary, Alberta, Canada

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NCT06133374

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