Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT05997810

Conditions

Parathyroid Tumor

Primary Hyperparathyroidism

Secondary Hyperparathyroidism (SHPT)

Tertiary Hyperparathyroidism

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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).

Conditions

Parathyroid Tumor

Primary Hyperparathyroidism

Secondary Hyperparathyroidism (SHPT)

Tertiary Hyperparathyroidism

Study ID

NCT05997810

Start date

Jul 28, 2023

Status verified date

May, 2026

Completion date

Jan 31, 2032

Anticipated

Primary completion date

Jan 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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.
  • Pregnant patients

Study Design

Enrollment

839 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Primary Endpoint 1 [ Time Frame: 24 months ]
  • Primary Endpoint 2 [ Time Frame: 24 months ]
  • Primary Endpoint 3 [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

John A Olson, MD

(314) 362-8020jaolsol@wustl.edu

Kathleen Harris

(314) 273-1433harrisk@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Bryan Bear

314-651-9717bearb@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-05-12.