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Comparing needle biopsy and surgery samples in papillary thyroid cancer

Compares results from a fine needle biopsy with surgical samples in papillary thyroid cancer.

Plain-language title generated from the registry record
Registry title: Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples

Key facts

Where
Calgary, CanadaSee the site

Where in Canada

  • Foothills Medical CentreCalgary, CanadaTaking people

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Trial details

Who runs it
University of Calgary
Trial code
NCT06133374
Record updated
15 January 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; Final pathology does not demonstrate papillary thyroid cancer; Unable or unwilling to have a fine needle biopsy; Unwilling to undergo thyroidectomy; Cases where there is no clear dominant nodule; Cases where there are multiple nodules that preclude sampling of a defined nodule.

ClinicalTrials.gov NCT06133374