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

Launched by UNIVERSITY OF CALGARY · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well results from a fine needle biopsy (a small, minimally invasive procedure to take a sample from a tumor) match with results from a larger sample taken during surgery in patients with papillary thyroid cancer. The goal is to see if both tests provide the same information about the cancer, which could help doctors make better treatment decisions.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of papillary thyroid cancer that shows specific features in the biopsy results. They should also have a tumor larger than 1 cm and be eligible for surgery. If you join the study, you’ll undergo both the fine needle biopsy and the surgical procedure, and your experiences will contribute to understanding the best ways to diagnose and treat this type of cancer. The trial is currently looking for participants, and it's important for those interested to know that certain factors, like a family history of thyroid cancer or previous neck radiation, may affect eligibility.

Gender

ALL

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 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