A Study to Assess an Intact Parathyroid Hormone Assay Under Development by Ortho Clinical Diagnostics

Overview

About this study

The purpose of this study is to collect patient samples to Ortho Clinical Diagnostics for evaluation of an in-development VITROS Intact PTH II assay and the characterization of different clinical cohorts on this immunoassay.  The categories include those for primary hyperparathyroidism, including routine samples and those intraoperative samples obtained during the course of a parathyroidectomy procedure, secondary hyperparathyroidism, including routine and intraoperative samples from patients with kidney failure tertiary hyperparathyroidism, primary hypoparathyroidism, and hypercalcemia of malignancy.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Patients Undergoing Parathyroidectomy:

  • ≥ 21 years of age
  • Undergoing first parathyroidectomy procedure.
  • Able to provide a minimum of 10 mL blood per collection timepoint, with a maximum of 20 mL blood per collection timepoint.

Exclusion Criteria - Patients Undergoing Parathyroidectomy:

  • Known HIV or Hepatitis C infection.

Inclusion Criteria - Patients with Hypoparathyroidism:

  • ≥ 21 years of age.
  • Clinical diagnosis of Hypoparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Hypoparathyroidism:

  • Known HIV or Hepatitis C infection.
  • Treatment with NATPARA < 18 hours prior to study blood collection.

Inclusion Criteria - Patients with Primary Hyperparathyroidism:

  • ≥ 21 years of age.
  • Clinical diagnosis of Primary Hyperparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Primary Hyperparathyroidism:

  • Known HIV or Hepatitis C infection.

Inclusion Criteria - Patients with Secondary Hyperparathyroidism:

  • ≥ 21 years of age.
  • eGFR of less than 20 mL/min/1.73 m^2 (can be from Standard of Care result).
  • Clinical diagnosis of Secondary Hyperparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Secondary Hyperparathyroidism:

  • Known HIV or Hepatitis C infection.

Inclusion Criteria - Patients with Hypercalcemia from Malignancy:

  • ≥ 21 years of age.
  • Calcium level of 10.3 mg/dL or higher (can be from recent Calcium result).
  • Clinical diagnosis of Hypercalcemia resulting from malignancy.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Hypercalcemia from Malignancy:

  • Known HIV or Hepatitis C infection.
  • Treatment with calcitonin.
  • Treatment with bisphosphonates (zoledronic acid, pamidronate) or Denosumab > 3 hours prior to study blood collection.

Inclusion Criteria - Patients with Tertiary Hyperparathyroidism:

  • ≥ 21 years of age.
  • Clinical diagnosis of Tertiary Hyperparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Tertiary Hyperparathyroidism:

  • Known HIV or Hepatitis C infection.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bart Clarke, M.D.

Open for enrollment

Contact information:

Julie Faust R.N.

(507)266-3242

Faust.Julie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20478023

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