RecruitingNCT05997810
Parathyroid Tumor Clonal Status
A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Primary Hyperparathyroidism
Sponsor
Washington University School of Medicine
Enrollment
839 participants
Start Date
Apr 11, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
To define the frequency of monoclonal-X and polyclonal-X tumors in PHPT participants having parathyroidectomy (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).
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- Diagnosed with nonfamilial primary hyperparathyroidism biochemically confirmed by measurement of serum calcium and intact PTH within 60 days of enrollment.
- Female.
- 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 Criteria7
- Patients with a history of cervicofacial irradiation.
- Patients with recurrent or persistent PHPT after prior PTX.
- Patients with secondary hyperparathyroidism due to renal failure on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis).
- Patients with tertiary hyperparathyroidism due to renal failure with or without history of renal transplantation.
- Patients receiving calcimimetic agents (e.g. cinacalcet / Sensipar) within 30 days of PTX.
- Patients currently taking lithium or with a history of lithium use.
- Pregnant patients
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05997810