Clinical Utility of Preoperative Thyroid GuidePx® Testing

N/ANot Yet RecruitingNCT07584447

University of Calgary85 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Papillary Thyroid Cancer Papillary Thyroid Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Decision impact

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).

Time frame: 18 months

Secondary Outcomes

Incidence of total thyroidectomies

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

Time frame: 18 months

Incidence of completion thyroidectomies

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

Time frame: 18 months

Recurrence outcomes

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).

Time frame: 36 months

Costs

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.

Central Contacts

Elleine Allapitan

CONTACT

4032208440 elleine.allapitan@ucalgary.ca

Todd McMullen

CONTACT

780-407-1108 tpm1@ualberta.ca

Data from ClinicalTrials.gov

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