NCT03474601

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2025

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2019

Enrollment Period

9.9 years

First QC Date

March 10, 2018

Last Update Submit

March 17, 2020

Conditions

Keywords

Pituitary DiseasesPituitary incidentalomaCentral Diabetes InsipidusPituitary Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Treatment outcome of pituitary diseases

    Remission rate

    Up to 10 years

Secondary Outcomes (1)

  • Complications of pituitary disease

    Up to 10 years

Study Arms (8)

Acromegaly

Patients diagnosed with acromegaly

Other: Dynamic hormone study and Magnetic resonance imaging

Cushing's disease

Patients diagnosed with Cushing's disease

Other: Dynamic hormone study and Magnetic resonance imaging

Hyperprolactinemia/prolactinomas

Patients diagnosed with hyperprolactinemia/prolactinoma

Other: Dynamic hormone study and Magnetic resonance imaging

Pituitary stalk lesions

Patients diagnosed with pituitary stalk lesions

Other: Dynamic hormone study and Magnetic resonance imaging

Nonfunctioning pituitary adenomas

Patients diagnosed with nonfunctioning pituitary adenomas

Other: Dynamic hormone study and Magnetic resonance imaging

Central diabetes insipidus

Patients diagnosed with central diabetes insipidus

Other: Dynamic hormone study and Magnetic resonance imaging

Craniopharyngioma

Patients diagnosed with craniopharyngiomas

Other: Dynamic hormone study and Magnetic resonance imaging

Others

Patients diagnosed with other suprasellar/parasellar lesions

Other: Dynamic hormone study and Magnetic resonance imaging

Interventions

1. Medical history 2. Imaging examination including brain magnetic resonance imaging 3. Blood (Basal hormone study and follow-up study) and pituitary tumor tissue

AcromegalyCentral diabetes insipidusCraniopharyngiomaCushing's diseaseHyperprolactinemia/prolactinomasNonfunctioning pituitary adenomasOthersPituitary stalk lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with pituitary disease at Seoul National University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • Patients who do not agree with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Pituitary tumor tissue

MeSH Terms

Conditions

Pituitary DiseasesAcromegalyDiabetes Insipidus, NeurogenicPituitary ACTH HypersecretionPituitary NeoplasmsProlactinoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesBone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismDiabetes InsipidusKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jung Hee Kim, M.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Hee Kim, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2018

First Posted

March 22, 2018

Study Start

March 15, 2015

Primary Completion

February 14, 2025

Study Completion

February 14, 2025

Last Updated

March 18, 2020

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations