A Study To Assess An Intact Parathyroid Hormone Assay Under Development By Ortho Clinical Diagnostics
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-010733
Sponsor Protocol Number: 19-010733
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.
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 m2 (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.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Bart Clarke, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available