Primary HyperparathyroidismNCT01409798
The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry
An observational study of Primary Hyperparathyroidism, run by University of Nebraska at 6 sites in United States.
Trial summary
The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 175 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Jun 2010to 27 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Otolaryngology, Head and Neck Surgery clinic patients
Who may be able to join
- 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.
Who cannot join
- -No history of primary hyperparathyroidism
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University Of Missiouri
Columbia, Missouri, 65212
University of Iowa
Iowa City, Iowa, 52242
Kansas University Medical Center
Lawrence, Kansas, 66160
University of Minnesota
Minneapolis, Minnesota, 55414
University of Nebraska Medical Center
Omaha, Nebraska, 681225
Sanford School of Medicine
Sioux Falls, South Dakota, 57105
About this study
The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.
Read the 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).
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Hyperparathyroidism, Hypercalcemia
- Medical subject headings
- Hyperparathyroidism, Primary, Hyperparathyroidism, Hypercalcemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study start9 Jun 2010
- Primary completion1 Dec 2014
- Study completion27 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Russell B Smith, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409798
- Sponsor's protocol ID
- 0324-10-EP
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2011
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry
- ClinicalTrials.gov ID
- NCT01409798
- Acronym / sponsor ID
- 0324-10-EP
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Hyperparathyroidism, Hypercalcemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 9 Jun 2010 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 27 Apr 2015 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry is to create a database that collects clinical data to improve knowledge about 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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Otolaryngology, Head and Neck Surgery clinic patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -No history of primary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell B Smith, MD principal investigator
University of Nebraska
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by University of Nebraska at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.