A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Primary Hyperparathyroidism
Washington University School of Medicine
Summary
To define the frequency of monoclonal-X and polyclonal-X tumors in PHPT participants having parathyroidectomy (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 primary hyperparathyroidism (PHPT) participants having parathyroidectomy (PTX) and to define the relationship between parathyroid tumor clonal status and multiple gland neoplasia (MGN), the investigators will compare surgical and pathologic outcomes to tumor clonal status in a multicenter cohort of participants having bilateral neck exploration (BNE) and PTX. Study participants will be recruited from four high-volume centers at Washington University in St. Louis (WU), University of California San Francisco, University of Alaba…
Eligibility
- Age range
- 18–80 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Diagnosed with nonfamilial primary hyperparathyroidism biochemically confirmed by measurement of serum calcium and intact PTH within 60 days of enrollment. * Female. * 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 with recurrent or persistent PHPT after prior PTX. * Patients with secondary hyperparathyroidism due to renal failure on renal replacement thera…
Location
- Washington University School of MedicineSt Louis, Missouri