Parathyroid HyperplasiaNCT02636075
"Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases"
An observational study of Parathyroid Hyperplasia, run by SB Istanbul Education and Research Hospital.
Trial summary
This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases or not. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parathyroid Hyperplasia
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Feb 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: no limitaion
Who may be able to join
- Patients who have undergone an operation due to parathyroid hyperplasia
Who cannot join
- -
About this study
This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases or not.
Read the detailed description
Parathyroid tissues gets heavier when they become Hyperplasia. Because of this weight change, they change their normal anatomic positions. 125 patients who have been operated earlier will be included in the study.
- Conditions
- Parathyroid Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upper 1/3 of thyroid tissue | Not described | |
| Middle 1/3 of thyroid tissue | Not described | |
| Lower 1/3 of thyroid tissue | Not described | |
| Below thyroid tissue | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the thyroid tissue
Longitudinal size (in mm) of each parathyroid tissue according to its anatomical location (upper, middle or lower 1/3 of the thyroid gland or below the thyroid)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid HyperplasiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
- Investigators
- Erhan Aysan, MD, Study director, Vakıf Gureba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636075
- Sponsor's protocol ID
- 123456ab
- Status last verified
- Dec 2015
- First submitted
- 5 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases"
- ClinicalTrials.gov ID
- NCT02636075
- Acronym / sponsor ID
- 123456ab
- Conditions
- Parathyroid Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 21 Dec 2015 (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.
This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases or not.
Detailed description
Parathyroid tissues gets heavier when they become Hyperplasia. Because of this weight change, they change their normal anatomic positions. 125 patients who have been operated earlier will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Upper 1/3 of thyroid tissue | – | – |
| Middle 1/3 of thyroid tissue | – | – |
| Lower 1/3 of thyroid tissue | – | – |
| Below thyroid tissue | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- no limitaion
Key inclusion criteria (1 listed)
- Patients who have undergone an operation due to parathyroid hyperplasia
Key exclusion criteria (1 listed)
- -
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
Size of the thyroid tissue
Time frame: one year
Longitudinal size (in mm) of each parathyroid tissue according to its anatomical location (upper, middle or lower 1/3 of the thyroid gland or below the thyroid)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
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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.
Erhan Aysan, MD study director
Vakıf Gureba University
Questions about this trial
What is this clinical trial studying?
An observational study of Parathyroid Hyperplasia, run by SB Istanbul Education and Research Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Size of the thyroid tissue (time frame: one year). It is what the study was designed to measure, not a finding.
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 21 Dec 2015.