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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474601
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jung Hee Kim, Seoul National University Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Pituitary Disease Pituitary Incidentaloma Acromegaly Central Diabetes Insipidus Pituitary Stalk Compression Hyperprolactinaemia Cushing's Disease Pituitary Tumor Prolactinoma Other: Dynamic hormone study and Magnetic resonance imaging

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 Design
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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seoul National University Pituitary Disease Cohort Study
Actual Study Start Date : March 15, 2015
Estimated Primary Completion Date : February 14, 2025
Estimated Study Completion Date : February 14, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Treatment outcome of pituitary diseases [ Time Frame: Up to 10 years ]
    Remission rate


Secondary Outcome Measures :
  1. Complications of pituitary disease [ Time Frame: Up to 10 years ]
    Visual field defect or hypopituitarism, hormone hyperfunction-related complications


Biospecimen Retention:   Samples Without DNA
Blood Pituitary tumor tissue

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with pituitary disease at Seoul National University Hospital
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474601


Contacts
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Contact: Jung Hee Kim, M.D 82-2-2072-4073 jhkxingfu@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Jung Hee Kim, M.D       jhkxingfu@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jung Hee Kim, M.D Seoul National University Hospital
More Information
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Responsible Party: Jung Hee Kim, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03474601    
Other Study ID Numbers: 1503-040-654
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jung Hee Kim, Seoul National University Hospital:
Pituitary Diseases
Pituitary incidentaloma
Central Diabetes Insipidus
Pituitary Neoplasms
Additional relevant MeSH terms:
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Acromegaly
Pituitary Neoplasms
ACTH-Secreting Pituitary Adenoma
Prolactinoma
Pituitary Diseases
Pituitary ACTH Hypersecretion
Hyperprolactinemia
Diabetes Insipidus
Diabetes Insipidus, Neurogenic
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Endocrine
 Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases