Pituitary DiseaseSNU-PITNCT03474601
Seoul National University Pituitary Disease Cohort Study
An observational study of Pituitary Disease and Pituitary Incidentaloma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the treatment and natural history of pituitary disease. We have a longstanding interest in pituitary disease including acromegaly, central diabetes insipidus, and nonfunctioning pituitary adenoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Disease, Pituitary Incidentaloma, Acromegaly
- What is being tested?
- Dynamic hormone study and Magnetic resonance imaging
- How many people
- 1,600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2015to 14 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with pituitary disease at Seoul National University Hospital
Who may be able to join
- Subjects for this study will be recruited if they are:
- Adults, male or female aged 18 years or older
- diagnosed with pituitary diseases such as acromegaly, Cushing's disease, hyperprolactinemia, nonfunctioning pituitary adenoma, pituitary stalk lesions, central diabetes insipidus, and craniopharyngiomas
Who cannot join
- Patients who do not agree with the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jung Hee Kim, M.D, jhkxingfu@gmail.com
About this study
The purpose of this study is to investigate the treatment and natural history of pituitary disease. We have a longstanding interest in pituitary disease including acromegaly, central diabetes insipidus, and nonfunctioning pituitary adenoma. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to pituitary disease.
Read the detailed description
Subjects for this study will be recruited if they are:
- Adults, male or female aged 18 years or older
- Have been diagnosed with pituitary diseases
- Conditions
- Pituitary Disease, Pituitary Incidentaloma, Acromegaly, Central Diabetes Insipidus, Pituitary Stalk Compression Hyperprolactinaemia, Cushing's Disease
- Being tested
- Dynamic hormone study and Magnetic resonance imaging
- Keywords
- Pituitary Diseases, Pituitary incidentaloma, Central Diabetes Insipidus, Pituitary Neoplasms
- Medical subject headings
- Pituitary Diseases, Acromegaly, Diabetes Insipidus, Neurogenic, Pituitary ACTH Hypersecretion, Pituitary Neoplasms, Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic hormone study and Magnetic resonance imagingOther
- Medical history
- Imaging examination including brain magnetic resonance imaging
- Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
| Study group | Role | What they receive |
|---|---|---|
| Acromegaly | Patients diagnosed with acromegaly Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Cushing's disease | Patients diagnosed with Cushing's disease Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Hyperprolactinemia/prolactinomas | Patients diagnosed with hyperprolactinemia/prolactinoma Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Pituitary stalk lesions | Patients diagnosed with pituitary stalk lesions Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Nonfunctioning pituitary adenomas | Patients diagnosed with nonfunctioning pituitary adenomas Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Central diabetes insipidus | Patients diagnosed with central diabetes insipidus Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Craniopharyngioma | Patients diagnosed with craniopharyngiomas Receives: Other: Dynamic hormone study and Magnetic resonance imaging | |
| Others | Patients diagnosed with other suprasellar/parasellar lesions Receives: Other: Dynamic hormone study and Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment outcome of pituitary diseases
Remission rate
Measured: Up to 10 years
Secondary outcomes (1)
Complications of pituitary disease
Visual field defect or hypopituitarism, hormone hyperfunction-related complications
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start15 Mar 2015
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hee Kim, Seoul National University Hospital
- Investigators
- Jung Hee Kim, M.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474601
- Sponsor's protocol ID
- 1503-040-654
- Acronym
- SNU-PIT
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seoul National University Pituitary Disease Cohort Study
- ClinicalTrials.gov ID
- NCT03474601
- Acronym / sponsor ID
- SNU-PIT / 1503-040-654
- Conditions
- Pituitary Disease, Pituitary Incidentaloma, Acromegaly, Central Diabetes Insipidus, Pituitary Stalk Compression Hyperprolactinaemia, Cushing's Disease
- Keywords
- Pituitary Diseases, Pituitary incidentaloma, Central Diabetes Insipidus, Pituitary Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Feb 2025 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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 study is to investigate the treatment and natural history of pituitary disease. We have a longstanding interest in pituitary disease including acromegaly, central diabetes insipidus, and nonfunctioning pituitary adenoma. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to pituitary disease.
Detailed description
Subjects for this study will be recruited if they are:
- Adults, male or female aged 18 years or older
- Have been diagnosed with pituitary diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Acromegaly | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with acromegaly |
| Cushing's disease | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with Cushing's disease |
| Hyperprolactinemia/prolactinomas | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with hyperprolactinemia/prolactinoma |
| Pituitary stalk lesions | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with pituitary stalk lesions |
| Nonfunctioning pituitary adenomas | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with nonfunctioning pituitary adenomas |
| Central diabetes insipidus | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with central diabetes insipidus |
| Craniopharyngioma | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with craniopharyngiomas |
| Others | – | Other: Dynamic hormone study and Magnetic resonance imagingPatients diagnosed with other suprasellar/parasellar lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pituitary disease at Seoul National University Hospital
Key inclusion criteria (3 listed)
- Subjects for this study will be recruited if they are:
Key exclusion criteria (1 listed)
- Patients who do not agree with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic hormone study and Magnetic resonance imaging1. Medical history 2. Imaging examination including brain magnetic resonance imaging 3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue | Other | Acromegaly, Central diabetes insipidus, Craniopharyngioma, Cushing's disease, Hyperprolactinemia/prolactinomas, Nonfunctioning pituitary adenomas, Others, Pituitary stalk lesions |
Primary outcome
Treatment outcome of pituitary diseases
Time frame: Up to 10 years
Remission rate
1 secondary outcome
Complications of pituitary disease
Time frame: Up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Jung Hee Kim, M.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Disease and Pituitary Incidentaloma, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Hee Kim, M.D (82-2-2072-4073, jhkxingfu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment outcome of pituitary diseases (time frame: Up to 10 years). 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 18 Mar 2020.