Understanding tumor types in patients with primary hyperparathyroidism
Official title: A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Hyperparathyroid Disorders (Primary, Secondary, and Tertiary)
Run by Washington University School of Medicine · NCT05997810 · Data updated 2026-11-12
This study is trying to see how often different types of tumors occur in people with primary hyperparathyroidism who are having surgery to remove their parathyroid glands.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 839 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | July 28, 2023 |
| Main results expected | January 31, 2031 |
| Study ends | January 31, 2032 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT05997810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are females aged 18 and older diagnosed with nonfamilial primary hyperparathyroidism.
✕Probably not a fit
Patients with recurrent or persistent primary hyperparathyroidism after prior surgery or those with secondary or tertiary hyperparathyroidism due to renal failure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to determine the frequency of monoclonal and polyclonal tumors in patients diagnosed with primary hyperparathyroidism who are undergoing parathyroidectomy. By comparing surgical and pathological outcomes with tumor clonal status, the study seeks to explore the relationship between tumor characteristics and multiple gland neoplasia. Participants will be recruited from four high-volume medical centers, and tumor samples will be analyzed using established genetic assays to ensure accurate clonal status determination.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of parathyroid tumors, potentially leading to improved treatment strategies for patients with primary hyperparathyroidism.
How similar studies have gone: Previous studies have shown a high concordance rate in tumor clonal status assessment, indicating that this approach has been validated in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: John A Olson, MD
- Email: jaolsol@wustl.edu
- Phone: (314) 362-8020
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.