This clinical trial tests how well preoperative molecular analysis using Thyroseq works to guide the type of surgery selected in treating patients with differentiated thyroid cancer. Thyroseq is a test that uses cells collected from the thyroid nodule during fine needle aspiration (FNA) to analyze DNA and RNA to help diagnose if a thyroid nodule is benign (non-cancerous) or malignant (cancerous). A thyroid lobectomy is a surgical procedure involving complete removal of a lobe of the thyroid gland containing the cancer. A total thyroidectomy is a surgical procedure involving the complete removal of the thyroid gland. Ideal surgical extent for differentiated thyroid cancer remains unclear. Routine use of molecular analysis in biopsy-proven thyroid cancer could provide important information to help guide extent of surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06235814.
PRIMARY OBJECTIVES:
I. Determine feasibility of a future multi-center prospective trial of routine preoperative molecular testing for papillary thyroid cancers to guide extent of therapy.
II. Determine the percent of eligible patients that undergo randomization to thyroid lobectomy versus total thyroidectomy and complete assigned treatment
III. Determine whether preoperative molecular testing predicts postoperative clinicopathologic findings by creating a registry tracking the final surgical pathology and clinical results.
OUTLINE: Patients' previously collected FNA biopsies are analyzed using the Thyroseq next-generation sequencing (NGS) panel. Patients with intermediate molecular-risk thyroid nodules are randomized to 1 of 2 arms.
ARM I: Patients undergo thyroid lobectomy on study. Patients also undergo ultrasound imaging on study and during follow up and may undergo FNA during follow up.
ARM II: Patients undergo total thyroidectomy on study. Patients also undergo ultrasound imaging on study and during follow up and may undergo FNA during follow up.
After completion of study intervention, patients are followed up at 14 and 28 days, and then 6, 12, 18, and 24 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorMasha Livhits
