Clinical trial · Observational
Parathyroid Tumor Clonal Status
A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Hyperparathyroid Disorders (Primary, Secondary, and Tertiary)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parathyroid Tumor | Parathyroid Gland Neoplasm | ALIAS | 0.90 |
| Primary Hyperparathyroidism | — | UNRESOLVED | — |
| Secondary Hyperparathyroidism (SHPT) | — | UNRESOLVED | — |
| Tertiary Hyperparathyroidism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Primary Endpoint 1
- timeFrame
- 24 months
- description
- 1\. Frequency of monoclonal-X versus polyclonal-X parathyroid tumors in patients with hyperparathyroid disorders.
- measure
- Primary Endpoint 2
- timeFrame
- 24 months
- description
- 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.
- measure
- Primary Endpoint 3
- timeFrame
- 24 months
- description
- Perform a prospective study of biochemical outcomes of PTX in PHPT patients with monoclonal-X and polyclonal-X tumors.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available