Recruiting

Molecular Classification

Sponsor:

University of Calgary

Code:

NCT06133374

Conditions

Papillary Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Papillary Thyroid Cancer

Study ID

NCT06133374

Start date

Jul 1, 2024

Status verified date

Dec, 2025

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Concordance between Thyroid GuidePx® molecular classifications acquired from FNAs and matched frozen surgical samples [ Time Frame: December 1, 2025 ]

Central Contacts and Locations

Central contacts

Elleine Allapitan

403-220-8440elleine.allapitan@ucalgary.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Elleine Allapitan

4032208440

More Information

Sponsor

University of Calgary

Last update posted

Jan 15, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-01-15.