Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples

January 13, 2026 updated by: University of Calgary
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.

Study Overview

Status

Recruiting

Conditions

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 doctor's estimate on whether the cancer is aggressive or not. Current methods for distinguishing aggressive tumors from less aggressive tumors rely on clinical factors as well as factors related to the final pathology (after the tumor has been removed). Ideally, the information required to make decisions would be available prior to surgery, so that surgical decisions can be made.

A new test is being developed to determine molecular features of a PTC and to estimate the risk of cancer recurrence after surgery. Thyroid GuidePx® provides unique information that may inform doctors' decisions. The greatest potential for Thyroid GuidePx® to impact on clinical care is if it can be performed prior to surgery on a fine needle biopsy (FNB). If Thyroid GuidePx® could be done on an FNB, it would inform surgeons on the type of surgery that would be most appropriate for an individual.

A recent feasibility study consisting of 12 patients with PTC demonstrated that performing the Thyroid GuidePx® assay on FNBs is feasible. However, reliance on a limited FNB for molecular disease characterization implies that the sample is representative of the entirety of the tumor. Genomic and transcriptomic heterogeneity has been described in primary tumors and metastases. Therefore, it will be important to document the concordance between samples acquired by FNB and surgical samples. The goal of this study is to determine whether the more limited sample from an FNB is sufficiently representative of the larger tumor to determine a valid molecular classification using the Thyroid GuidePx® test in patients with PTC.

Participants will be invited to participate if they have a preoperative tissue diagnosis of PTC (Bethesda VI) or suspicious for PTC (Bethesda V), and they are eligible for partial or total thyroidectomy. During surgery, when the thyroid gland and the tumor are exposed, the surgeon will perform an FNB of the dominant tumor (ie: the lesion identified preoperatively), under direct vision. The cellular material from the FNB will be sent for processing. Separate surgical samples will be processed and examined. This will follow routine specimen processing protocols and will not interfere with standard methods of pathologic diagnosis. Tissue will be released for research only once sufficient tissue is taken for diagnostic and clinical use. RNASeq for Thyroid GuidePx® for both FNB and surgical samples will be performed and compared.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • Foothills Medical Centre
        • Contact:
          • Elleine Allapitan
          • Phone Number: 4032208440
        • Sub-Investigator:
          • Adrian Harvey, MD
        • Sub-Investigator:
          • Janice Pasieka, MD
        • Sub-Investigator:
          • Shamir Chandarana, MD
        • Sub-Investigator:
          • Robert Hart, MD
        • Sub-Investigator:
          • Wayne Matthews, MD
        • Sub-Investigator:
          • Martin Hyrcza, MD/PhD
        • Sub-Investigator:
          • Moosa Khalil, MD
        • Sub-Investigator:
          • Anthony Magliocco, MD
        • Sub-Investigator:
          • Karen Kopciuk, PhD
        • Sub-Investigator:
          • Tasnima Abedin, PhD
        • Sub-Investigator:
          • Faisal Khan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a preoperative tissue diagnosis of PTC (Bethesda VI) or suspicious for PTC (Bethesda V) or a tissue diagnosis 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, eligible for partial or total thyroidectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between Thyroid GuidePx® molecular classifications acquired from FNAs and matched frozen surgical samples
Time Frame: December 1, 2025
The molecular class assignment (Type 1, Type 2 and Type 3), based on the pattern of expression of prognostic genes, will be compared between samples obtained by FNB and matched frozen surgical specimens. The significance of concordance between the two sample types will be determined using the kappa statistic.
December 1, 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The technical success rate in completing a valid Thyroid GuidePx® using FNB and FFPE surgical samples
Time Frame: December 1, 2025
Sufficient RNA of good quality to perform the test
December 1, 2025
The recurrence outcomes using the ATA risk stratification system vs. patients classified by Thyroid GuidePx® using surgical samples
Time Frame: May 1, 2028
Biochemical and structural recurrence
May 1, 2028
The test performance of Thyroid GuidePx® as a prognostic test (FNB and surgical samples) in comparison to ATA Risk Stratification.
Time Frame: May 1, 2028
Specificity, sensitivity, AUROC, positive predictive value, and negative predictive value,
May 1, 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Health services
Qualisure Diagnostics Inc.

Investigators

  • Principal Investigator: Caitlin Yeo, MD, Alberta Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA.CC-23-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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