Seoul National University Pituitary Disease Cohort Study (SNU-PIT)

March 17, 2020 updated by: Jung Hee Kim, Seoul National University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects for this study will be recruited if they are:

  1. Adults, male or female aged 18 years or older
  2. Have been diagnosed with pituitary diseases

Study Type

Observational

Enrollment (Anticipated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with pituitary disease at Seoul National University Hospital

Description

Inclusion Criteria:

  • Subjects for this study will be recruited if they are:

    1. Adults, male or female aged 18 years or older
    2. diagnosed with pituitary diseases such as acromegaly, Cushing's disease, hyperprolactinemia, nonfunctioning pituitary adenoma, pituitary stalk lesions, central diabetes insipidus, and craniopharyngiomas

Exclusion Criteria:

  • Patients who do not agree with the study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acromegaly
Patients diagnosed with acromegaly
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Cushing's disease
Patients diagnosed with Cushing's disease
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Hyperprolactinemia/prolactinomas
Patients diagnosed with hyperprolactinemia/prolactinoma
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Pituitary stalk lesions
Patients diagnosed with pituitary stalk lesions
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Nonfunctioning pituitary adenomas
Patients diagnosed with nonfunctioning pituitary adenomas
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Central diabetes insipidus
Patients diagnosed with central diabetes insipidus
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Craniopharyngioma
Patients diagnosed with craniopharyngiomas
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue
Others
Patients diagnosed with other suprasellar/parasellar lesions
Other: Dynamic hormone study and Magnetic resonance imaging
  1. Medical history
  2. Imaging examination including brain magnetic resonance imaging
  3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment outcome of pituitary diseases
Time Frame: Up to 10 years
Remission rate
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of pituitary disease
Time Frame: Up to 10 years
Visual field defect or hypopituitarism, hormone hyperfunction-related complications
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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)

March 15, 2015

Primary Completion (ANTICIPATED)

February 14, 2025

Study Completion (ANTICIPATED)

February 14, 2025

Study Registration Dates

First Submitted

March 10, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (ACTUAL)

March 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1503-040-654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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