Understanding tumor types in patients with primary hyperparathyroidism
A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Hyperparathyroid Disorders (Primary, Secondary, and Tertiary)
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 |
|---|---|
| Enrollment | 839 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05997810 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 and older diagnosed with nonfamilial primary hyperparathyroidism.
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.
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 performed: Previous studies have shown a high concordance rate in tumor clonal status assessment, indicating that this approach has been validated in similar contexts.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.