Concordance of Molecular Classification Using Fine Needle Biopsy and Surgical Samples in Papillary Thyroid Cancer

What this Trial Is About

This research investigates papillary thyroid carcinoma (PTC), a common thyroid cancer, focusing on whether molecular test results from a fine needle biopsy (FNB) match those from larger surgical samples. The goal is to see if the Thyroid GuidePx test can accurately classify tumors and estimate recurrence risk using small biopsy samples before surgery, which could help guide surgical decisions more effectively. The study is observational and examines the molecular features and heterogeneity of PTC tumors. Participants with a diagnosis or suspicion of PTC who are candidates for thyroid surgery will be included. During surgery, the surgeon will perform an FNB of the main tumor to collect cells for molecular testing with the Thyroid GuidePx assay. Surgical samples will also be collected and processed routinely for comparison. This approach ensures that molecular classifications from FNB and surgical samples can be compared without interfering with standard pathology. Participants will undergo tissue sampling during surgery, and both FNB and surgical specimens will be analyzed using RNA sequencing for molecular classification. Researchers will measure the agreement between molecular test results from the two sample types. They will also assess the technical success of the test, risk of cancer recurrence, and how the test compares to current risk stratification methods. The study includes follow-up to monitor outcomes, with participation lasting until May 2028.

Concordance of Molecular Classification Based on Fine Needle Biopsy (FNB) and Surgical Samples