NCT06133374 Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples
| NCT ID | NCT06133374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Papillary Thyroid Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2024-07-01 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Caitlin Yeo, MD
PRINCIPAL INVESTIGATOR
Alberta Health services
Frequently Asked Questions
Who can join the NCT06133374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Papillary Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06133374 currently recruiting?
Yes, NCT06133374 is actively recruiting participants. Contact the research team at elleine.allapitan@ucalgary.ca for enrollment information.
Where is the NCT06133374 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT06133374 clinical trial?
NCT06133374 is sponsored by University of Calgary. The principal investigator is Caitlin Yeo, MD at Alberta Health services. The trial plans to enroll 130 participants.
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