Observational Study on Parathyroid Tumor Clonal Status

This observational study aims to understand the characteristics of parathyroid tumors in people with hyperparathyroidism (a condition where your parathyroid glands make too much parathyroid hormone). Researchers want to find out how often tumors are made of one type of cell (monoclonal) versus many types of cells (polyclonal). They will also look at how this relates to having multiple affected glands. You could be eligible if you are between 18 and 80 years old, male or female, and have been diagnosed with primary, secondary, or tertiary hyperparathyroidism. The study will analyze tumor samples collected during your standard parathyroidectomy surgery. The goal is to compare surgical and lab results with the tumor's cell type over 24 months to better understand these conditions.

Study design
This is an observational study planning to enroll 839 participants. It will compare surgical and pathological outcomes to the clonal status of parathyroid tumors.
What's involved
You will receive standard of care treatment (parathyroidectomy). De-identified tumor samples from your surgery will be sent for study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes of the study will be measured at 24 months.

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NCT05997810

Parathyroid Tumor Clonal Status

Recruiting
Not specifiedAges 18–80Observational
Washington University School of Medicine
~839 participants
Updated 2026-05-12 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint 1
Measured over 24 months
+2 more outcomes measured
Parathyroid Tumor
Primary Hyperparathyroidism
Secondary Hyperparathyroidism (SHPT)
Tertiary Hyperparathyroidism
1 sites across 1 states
Missouri1

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Eligibility criteria

Inclusion

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

Patients with a history of cervicofacial irradiation.
Patients currently taking lithium or with a history of lithium use.
Pregnant patients
  • Primary Endpoint 124 months

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

  • Primary Endpoint 224 months

    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 324 months

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