Clinical Utility of Preoperative Thyroid GuidePx® Testing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients newly diagnosed with papillary thyroid cancer (Bethesda V and VI cytology) with localized disease who can potentially be treated with lobectomy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
85 Participants
are grouped into 1 trial groupGroup A: Thyroid GuidePx® Tested Cohort
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Incidence of total thyroidectomies
Incidence of total thyroidectomy of the tested cohort will be compared to historical controls.
Time frame
18 months2
Incidence of completion thyroidectomies
Incidence of completion thyroidectomy of the tested cohort will be compared to historical controls.
Time frame
18 months3
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 months4
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.
Time frame
18 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Qualisure Diagnostics Inc.
Collaborator
University of Alberta
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: