SNU-PIT: Seoul National University Pituitary Disease Cohort Study

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03474601
• Collaborator: (none)
• Enrollment: 1,600
• Location: 1
• Anticipated Duration (Months): 119.1
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated Enrollment: 1600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Seoul National University Pituitary Disease Cohort Study
• Actual Study Start Date: Mar 15, 2015
• Anticipated Primary Completion Date: Feb 14, 2025
• Anticipated Study Completion Date: Feb 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Acromegaly Patients diagnosed with acromegaly	Other: Dynamic hormone study and Magnetic resonance imaging; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging 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; Medical history Imaging examination including brain magnetic resonance imaging Blood (Basal hormone study and follow-up study) and pituitary tumor tissue

Outcome Measures

Primary Outcome Measures

1. Treatment outcome of pituitary diseases [Up to 10 years]

   Remission rate

Secondary Outcome Measures

1. Complications of pituitary disease [Up to 10 years]

   Visual field defect or hypopituitarism, hormone hyperfunction-related complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jung Hee Kim, M.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jung Hee Kim, Principal Investigator, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03474601
• Other Study ID Numbers: 1503-040-654
• First Posted: Mar 22, 2018
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jung Hee Kim, Principal Investigator, Seoul National University Hospital: Pituitary Diseases; Pituitary incidentaloma; Central Diabetes Insipidus; Pituitary Neoplasms
• Additional relevant MeSH terms: Pituitary Neoplasms; ACTH-Secreting Pituitary Adenoma; Prolactinoma; Acromegaly; Pituitary Diseases; Pituitary ACTH Hypersecretion; Hyperprolactinemia; Diabetes Insipidus; Diabetes Insipidus, Neurogenic; Hormones

Study Results

No Results Posted as of Mar 18, 2020