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Status:

RECRUITING

Parathyroid Tumor Clonal Status

Lead Sponsor:

Washington University School of Medicine

Conditions:

Parathyroid Tumor

Primary Hyperparathyroidism

Eligibility:

FEMALE

18-80 years

Brief 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 ...

Detailed Description

To define the frequency of monoclonal-X and polyclonal-X tumors in primary hyperparathyroidism (PHPT) participants having parathyroidectomy (PTX) and to define the relationship between parathyroid tum...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 11 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2027

Estimated Enrollment :

839 Patients enrolled

Trial Details

Trial ID

NCT05997810

Start Date

April 11 2023

End Date

January 1 2027

Last Update

January 20 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Alabama-Birmingham

Birmingham, Alabama, United States, 35233

2

University of California-Department of Surgery

San Francisco, California, United States, 94143

3

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104