Parathyroid Tumor Clonal Status

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorWashington University School of Medicine

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Primary Endpoint 1

1\. Frequency of monoclonal-X versus polyclonal-X parathyroid tumors in patients with hyperparathyroid disorders.

Time frame
24 months
2

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.

Time frame
24 months
3

Primary Endpoint 3

Perform a prospective study of biochemical outcomes of PTX in PHPT patients with monoclonal-X and polyclonal-X tumors.

Time frame
24 months

Secondary outcomes

1

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).

Time frame
24 months

Other outcomes

Sponsors and contacts

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