RecruitingNot Applicable

Parathyroid Tumor Clonal Status

United States839 participantsStarted 2023-07-28

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Primary Endpoint 1

Timeframe: 24 months

Primary Endpoint 2

Timeframe: 24 months

Primary Endpoint 3

Timeframe: 24 months

Trial details

NCT IDNCT05997810

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-01-31

Contact for this trial

John A Olson, MD

(314) 362-8020 jaolsol@wustl.edu

View on ClinicalTrials.gov More Parathyroid Tumor trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.