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

Overview

Información sobre este estudio

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.

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Bart Clarke, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20478023

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