A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Hyperparathyroid Disorders (Primary, Secondary, and Tertiary)
Washington University School of Medicine
Summary
To define the frequency of monoclonal-X and polyclonal-X tumors in hyperparathyroid disorders patients having PTX and to define the relationship between parathyroid tumor clonal status and multiple gland neoplasia (MGN), we will compare surgical and pathologic outcomes to tumor clonal status in a multicenter cohort of patients having bilateral neck exploration (BNE) and PTX (primary objectives).
Description
To define the frequency of monoclonal-X and polyclonal-X tumors in PHPT patients having PTX and to define the relationship between parathyroid tumor clonal status and MGN, we will compare surgical and pathologic outcomes to tumor clonal status in a multicenter cohort of patients having bilateral neck exploration (BNE) and PTX. Study participants will be recruited from four high-volume centers at Washington University in St. Louis (WU. Eligible patients will receive standard of care treatment (parathyroidectomy) and de-identified FFPE tumor samples (1 slide H\&E stained, 6 x 10 um sections uns…
Eligibility
- Age range
- 18–80 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 1\. Diagnosed with hyperparathyroidism (primary, secondary, or tertiary), biochemically confirmed (e.g., serum calcium and/or intact PTH consistent with the underlying etiology), and undergoing clinically indicated management * Female and male patients * Age ≥ 18 years * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Patients with a history of cervicofacial irradiation. * Patients currently taking lithium or with a history of lithium use…
Location
- Washington University School of MedicineSt Louis, Missouri