Actively Recruiting
A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Hyperparathyroid Disorders (Primary, Secondary, and Tertiary)
Led by Washington University School of Medicine · Updated on 2026-05-12
839
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the frequency of monoclonal-X and polyclonal-X tumors in patients with hyperparathyroid disorders who are undergoing parathyroidectomy (PTX). The study aims to understand how tumor clonal status relates to multiple gland neoplasia (MGN) by comparing surgical and pathological outcomes in patients having bilateral neck exploration (BNE) and PTX. This observational study collects data from multiple centers to explore the biology of parathyroid tumors and their clinical impact. Participants will receive standard parathyroidectomy treatment, and de-identified tumor tissue samples will be analyzed using DNA assays, including the HUMARA assay and Cytoscan HD array, to determine tumor clonality. The study compares outcomes of different surgical approaches such as unilateral neck exploration with intraoperative PTH monitoring and bilateral neck exploration. Tumor clonality will be assessed with multiple methods to ensure accuracy, and additional genomic sequencing may be performed on tumor tissue. Throughout the study, clinical and biochemical data such as serum calcium, intact PTH, vitamin D levels, and creatinine will be collected before surgery and at 2 weeks, 3 months, and 6 months afterward. Researchers will monitor biochemical outcomes related to tumor clonality and vitamin D metabolism. Surgical and pathological reports, intraoperative PTH levels, and tumor tissue analyses will be recorded and correlated. The study will follow participants for up to 24 months to evaluate primary and secondary endpoints related to tumor status and clinical outcomes.
CONDITIONS
Brief Title
Parathyroid Tumor Clonal Status
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hyperparathyroidism (primary, secondary, or tertiary), confirmed by blood tests and undergoing clinically indicated treatment
- Female or male patients
- Age 18 years or older
- Able to understand and willing to sign informed consent
You will not qualify if you...
- History of cervicofacial irradiation
- Current or past use of lithium
- Pregnant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo parathyroidectomy as standard of care treatment with surgical and pathologic outcomes recorded.
1 surgery visit (in-person)
Duration - 6 months
Participants provide tumor samples and clinical data for genomic and biochemical analysis to assess tumor clonal status and outcomes.
Visits at baseline, 2 weeks, 3 months, and 6 months post-surgery
Duration - Up to 24 months
Participants' clinical and biochemical outcomes are observed up to 24 months to evaluate primary and secondary endpoints.
Follow-up visits as per routine clinical care up to 24 months
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
J
John A Olson, MD
K
Kathleen Harris
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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