About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Patients with a history of cervicofacial irradiation.
Patients currently taking lithium or with a history of lithium use.
Pregnant patients
Trial population
Females and males scheduled to have surgery for hyperparathyroidism.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary Endpoint 1
1\. Frequency of monoclonal-X versus polyclonal-X parathyroid tumors in patients with hyperparathyroid disorders.
Primary Endpoint 2
2\. To determine the clinicopathologic features of monoclonal-X versus polyclonal-X parathyroid tumors in a prospective multi-center cohort of patients with HPT (PHPT/SHPT/THPT) referred for PTX.
Primary Endpoint 3
Perform a prospective study of biochemical outcomes of PTX in PHPT patients with monoclonal-X and polyclonal-X tumors.
Secondary outcomes
Secondary Endpoint
To investigate mechanism(s) of monoclonal-X and polyclonal-X parathyroid tumorigenesis using functional and genomic approaches (e.g. calcium sensing capacity determined by EC50 and single nucleotide variants / copy number variation).
Sponsors and contacts
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