Clinical Utility of Preoperative Thyroid GuidePx® Testing

May 28, 2026 updated by: University of Calgary
The purpose of this study is to learn whether having Thyroid GuidePx® test results available before treatment may help patients with papillary thyroid cancer and doctors make better-informed treatment decisions.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

85

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 Contact Backup

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

Non-Probability Sample

Study Population

Patients newly diagnosed with papillary thyroid cancer (Bethesda V and VI cytology) with localized disease who can potentially be treated with lobectomy

Description

Inclusion Criteria:

  • Patients aged 18 years or older at the time of enrollment
  • English-speaking
  • Bethesda V or VI cytology following FNA of a thyroid nodule (papillary thyroid cancer)
  • Bethesda III or IV with ThyroSpec positive for BRAFV600E, TERT, rearrangements in BRAF, RET, NTRK1, NTRK3, RAS + TERT, RAS + EIF1AX, AKT1, PI3CA, CTNNB1, EGFR, rearrangements in ALK
  • Tumor 1- 4cm in size
  • No lymph node involvement on ultrasound
  • No gross extrathyroidal extension on ultrasound

Exclusion Criteria:

  • Prior thyroid operation
  • Distant metastatic disease
  • Personal history of thyroid cancer
  • History of whole-body radiation exposure or radiation to the head and neck region

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

Cohorts and Interventions

Group / Cohort
Thyroid GuidePx® Tested Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision impact
Time Frame: 18 months

Decision impact is defined as any change in treatment decision based on the Thyroid GuidePx® test results, including changes in surgical approach, reduction of unnecessary treatments, and addition of recommended treatments. Decision impact is measured using study-specific clinician and patient questionnaires administered before and after test results are available. Clinician decision impact is assessed by comparing treatments considered prior to testing with treatments recommended after review of test results, as well as clinician agreement with the statement "The test helped to make a treatment decision" rated on a 5-point Likert scale. Patient decision impact is assessed by patient report of whether the test helped them make a treatment-related decision (Yes/No) and the degree to which the test contributed to their care.

A copy of the questionnaires can be uploaded as required (study document upload is currently disabled).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of total thyroidectomies
Time Frame: 18 months
Incidence of total thyroidectomy of the tested cohort will be compared to historical controls.
18 months
Incidence of completion thyroidectomies
Time Frame: 18 months
Incidence of completion thyroidectomy of the tested cohort will be compared to historical controls.
18 months
Recurrence outcomes
Time Frame: 36 months
Recurrence outcomes, including biochemical recurrence (i.e., thyroglobulin ≥ 1 ng/mL) and/or tumor recurrence confirmed by imaging (i.e., CT, Ultrasound, etc.) of the tested cohort will be compared to historical controls. In the tested cohort, recurrence outcomes will be compared in Type 3 PTC (high risk) to Type 1 and 2 PTC (low risk).
36 months
Costs
Time Frame: 18 months
Costs related to treatment and follow-up will be compared in the tested cohort will be compared to historical controls For the cost analysis, costs related to clinician visits, treatments and complications will be compared in the study cohort and historical controls.
18 months

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

University of Alberta
Qualisure Diagnostics Inc.

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA.CC-25-0488

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

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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