Status:
RECRUITING
Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Qualisure Diagnostics Inc.
Alberta Health services
Conditions:
Papillary Thyroid Cancer
Eligibility:
All Genders
18+ years
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®...
Detailed Description
Thyroid cancer is the 8th most common cancer, and incidence has been increasing. Papillary thyroid carcinoma (PTC) accounts for most thyroid cancers. Treatment decisions related to PTC depend on the d...
Eligibility Criteria
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.
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06133374
Start Date
July 1 2024
End Date
May 1 2028
Last Update
May 25 2025
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1N4