- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409798
The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry
August 30, 2023 updated by: University of Nebraska
The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
175
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Kansas
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Lawrence, Kansas, United States, 66160
- Kansas University Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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Missouri
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Columbia, Missouri, United States, 65212
- University Of Missiouri
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Nebraska
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Omaha, Nebraska, United States, 681225
- University of Nebraska Medical Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Sanford School of Medicine
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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.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Otolaryngology, Head and Neck Surgery clinic patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Russell B Smith, MD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
April 27, 2015
Study Registration Dates
First Submitted
August 2, 2011
First Submitted That Met QC Criteria
August 2, 2011
First Posted (Estimated)
August 4, 2011
Study Record Updates
Last Update Posted (Actual)
September 6, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0324-10-EP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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