NCT06133374Recruiting
Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 10 Nov 2023
- Start date
- 1 Jul 2024
- Primary completion date
- 30 May 2028
- Lead sponsor
- University of Calgary
- Diseases
- Thyroid cancer
- NCT number
- NCT06133374
What you commit to
- Study type: Observational
- Planned participants: 130
- From 1 Jul 2024 to the primary completion date, 30 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Foothills Medical Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.