Clinical trial · Observational
Clinical Utility of Preoperative Thyroid GuidePx® Testing
NCT07584447CI-TRIAL-00113086not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
| Papillary Thyroid Carcinoma | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Thyroid GuidePx® Tested Cohort
Primary outcomes (1)
- measure
- Decision impact
- timeFrame
- 18 months
- description
- 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 (4)
- measure
- Incidence of total thyroidectomies
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (21)
- RESULTChan WWL, Chan S, Kwong DLW. Radioiodine Refractory Differentiated Thyroid Cancer. Methods Mol Biol. 2022;2534:243-257. doi: 10.1007/978-1-0716-2505-7_17. PMID 35670980
- RESULTTuttle RM, Li D, Ridouani F. Percutaneous ablation of low-risk papillary thyroid cancer. Endocr Relat Cancer. 2023 Feb 11;30(3):e220244. doi: 10.1530/ERC-22-0244. Print 2023 Mar 1. PMID 36629393
- RESULTPace-Asciak P, Russell JO, Tufano RP. The Treatment of Thyroid Cancer With Radiofrequency Ablation. Tech Vasc Interv Radiol. 2022 Jun;25(2):100825. doi: 10.1016/j.tvir.2022.100825. Epub 2022 Mar 10. PMID 35551804
- RESULTYoon JH, Choi W, Park JY, Hong AR, Kim HK, Kang HC. Active Surveillance for Low-Risk Papillary Thyroid Carcinoma as an Acceptable Management Option with Additional Benefits: A Comprehensive Systematic Review. Endocrinol Metab (Seoul). 2024 Feb;39(1):152-163. doi: 10.3803/EnM.2023.1794. Epub 2024 Jan 22. PMID 38417830
- RESULTZhang M, He X, Wu J, Xie F. Differences between physician and patient preferences for cancer treatments: a systematic review. BMC Cancer. 2023 Nov 18;23(1):1126. doi: 10.1186/s12885-023-11598-4. PMID 37980466
- RESULTSchumm MA, Shu ML, Kim J, Tseng CH, Zanocco K, Livhits MJ, Leung AM, Yeh MW, Sacks GD, Wu JX. Perception of risk and treatment decisions in the management of differentiated thyroid cancer. J Surg Oncol. 2022 Aug;126(2):247-256. doi: 10.1002/jso.26858. Epub 2022 Mar 22. PMID 35316538
- RESULTChan S, Karamali K, Kolodziejczyk A, Oikonomou G, Watkinson J, Paleri V, Nixon I, Kim D. Systematic Review of Recurrence Rate after Hemithyroidectomy for Low-Risk Well-Differentiated Thyroid Cancer. Eur Thyroid J. 2020 Feb;9(2):73-84. doi: 10.1159/000504961. Epub 2020 Jan 28. PMID 32257956