Phase 2 Study on Parathyroid Tumor Clonal Status in Adults with Hyperparathyroid Disorders Undergoing Parathyroidectomy

What this Trial Is About

Researchers are studying the frequency of monoclonal-X and polyclonal-X tumors in patients with hyperparathyroid disorders who are undergoing parathyroidectomy PTX. The study aims to understand how tumor clonal status relates to multiple gland neoplasia MGN by comparing surgical and pathological outcomes in patients having bilateral neck exploration BNE and PTX. This observational study collects data from multiple centers to explore the biology of parathyroid tumors and their clinical impact. Participants will receive standard parathyroidectomy treatment, and de-identified tumor tissue samples will be analyzed using DNA assays, including the HUMARA assay and Cytoscan HD array, to determine tumor clonality. The study compares outcomes of different surgical approaches such as unilateral neck exploration with intraoperative PTH monitoring and bilateral neck exploration. Tumor clonality will be assessed with multiple methods to ensure accuracy, and additional genomic sequencing may be performed on tumor tissue. Throughout the study, clinical and biochemical data such as serum calcium, intact PTH, vitamin D levels, and creatinine will be collected before surgery and at 2 weeks, 3 months, and 6 months afterward. Researchers will monitor biochemical outcomes related to tumor clonality and vitamin D metabolism. Surgical and pathological reports, intraoperative PTH levels, and tumor tissue analyses will be recorded and correlated. The study will follow participants for up to 24 months to evaluate primary and secondary endpoints related to tumor status and clinical outcomes.

Parathyroid Tumor Clonal Status