Comparing biopsy results to surgical samples in thyroid cancer
Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples
This study is testing if the results from small needle biopsies of thyroid cancer match up with those from larger surgical samples to help doctors make better treatment decisions for patients with papillary thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06133374 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether the molecular classification of papillary thyroid cancer obtained from fine needle biopsies (FNB) aligns with results from surgical samples using the Thyroid GuidePx® test. By analyzing the molecular features of tumors, the study seeks to provide critical information that could guide surgical decisions before the actual surgery takes place. The research focuses on patients diagnosed with papillary thyroid carcinoma, particularly those with specific cytological classifications. The goal is to determine if FNB can reliably inform treatment strategies and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of papillary thyroid cancer based on specific biopsy results.
Not a fit: Patients with a history of neck radiation or those unable to undergo a fine needle biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable more personalized surgical approaches for patients with papillary thyroid cancer, potentially reducing unnecessary surgeries.
How similar studies have performed: Previous feasibility studies have shown promise in using fine needle biopsies for molecular characterization, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Caitlin Yeo, MD — Alberta Health services
- Study coordinator: Elleine Allapitan
- Email: elleine.allapitan@ucalgary.ca
- Phone: 403-220-8440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.