Parathyroid Tumor Clonal Status

Description

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).

Conditions

Parathyroid Tumor, Primary Hyperparathyroidism

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Study Overview

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Study Details

Study overview

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).

A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Primary Hyperparathyroidism

Parathyroid Tumor Clonal Status

Condition
Parathyroid Tumor
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama-Birmingham, Birmingham, Alabama, United States, 35233

San Francisco

University of California-Department of Surgery, San Francisco, California, United States, 94143

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington University School of Medicine,

Study Record Dates

2027-01