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NCT Number: NCT07584447

Clinical Utility of Preoperative Thyroid GuidePx® Testing

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.

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Papillary Thyroid Carcinoma Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Incidence of total thyroidectomies

    Time frame: 18 months

    Incidence of total thyroidectomy of the tested cohort will be compared to historical controls.

  2. Incidence of completion thyroidectomies

    Time frame: 18 months

    Incidence of completion thyroidectomy of the tested cohort will be compared to historical controls.

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elleine Allapitan

CONTACT

[email protected]

4032208440

Todd McMullen

CONTACT

[email protected]

780-407-1108

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Qualisure Diagnostics Inc.
  • University of Alberta

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 13, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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