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The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01409798
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.

Condition or disease
Primary Hyperparathyroidism

Detailed Description:
This will be a multi-institutional prospective study in which patients that have undergone parathyroidectomy with intra-operative PTH assessment. The success of minimally invasive parathyroidectomy without and with intra-operative PTH will be assessed for each patient. Success for exploration without intra-operative PTH will be defined as directed exploration with detection of an abnormal parathyroid in the location suggested by imaging. Success with intra-operative PTH will be defined as per standard protocols (50% or > decrease in intra-operative PTH following excision).

Study Design

Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry
Study Start Date : June 2010
Primary Completion Date : December 2014
Study Completion Date : November 2015


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Otolaryngology, Head and Neck Surgery clinic patients
Criteria

Inclusion Criteria:

  • Adult individuals (male and female) who have a personal diagnosis/history of primary hyperparathyroidism.
  • Age 19 or greater.
  • Patients who are seen and treated surgically at UNMC's Department of Otolaryngology- Head Neck Surgery .
  • Able to provide informed consent.

Exclusion Criteria:

-No history of primary hyperparathyroidism

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409798


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Lawrence, Kansas, United States, 66160
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Missouri
University Of Missiouri
Columbia, Missouri, United States, 65212
United States, Nebraska
University of Nebraska Medical Center
Omaha,, Nebraska, United States, 681225
United States, South Dakota
Sanford School of Medicine
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Russell B Smith, MD University of Nebraska
More Information

Responsible Party: Russell Smith MD, Professor, Vice Chairman, University of Nebraska
ClinicalTrials.gov Identifier: NCT01409798     History of Changes
Other Study ID Numbers: 324-10-EP
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Russell Smith MD, University of Nebraska:
Hyperparathyroidism
Hypercalcemia

Additional relevant MeSH terms:
Head and Neck Neoplasms
Hyperparathyroidism
Hyperparathyroidism, Primary
Neoplasms by Site
Neoplasms
Parathyroid Diseases
Endocrine System Diseases