A Prospective Cohort Study for Patients With Adrenal Diseases

March 16, 2020 updated by: Jung Hee Kim, Seoul National University Hospital
The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

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

Study Locations

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

study population of this study is the patients who are newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Description

Inclusion Criteria:

  • Adults, male or female aged 19 years or older
  • newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Exclusion Criteria:

  • previous or current history of adrenal diseases
  • using oral or intravenous steroids
  • history of major depressive disorder
  • history of chronic alcoholics
  • history of any cancer with suspicious adrenal metastasis
  • those with acute illness (ex- patients with acute coronary syndrome within 4 weeks, acute febrile disease)

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
Non-functioning adrenal incidentaloma
patients who were diagnosed with non-functioning adrenal incidentaloma on computed tomography or magnetic resonance imaging
Other: Hormone study and Imaging study
  1. Blood (basal hormone and follow up hormone study)
  2. Imaging examination including computed tomography scan or magnetic resonance imaging
Pheochromocytoma
patients who were diagnosed with pheochromocytoma biochemically or histologically
Other: Hormone study and Imaging study
  1. Blood (basal hormone and follow up hormone study)
  2. Imaging examination including computed tomography scan or magnetic resonance imaging
Primary aldosteronism
patients who were diagnosed with primary aldosteronism by saline loading test
Other: Hormone study and Imaging study
  1. Blood (basal hormone and follow up hormone study)
  2. Imaging examination including computed tomography scan or magnetic resonance imaging
Adrenal cushing syndrome
patients who were diagnosed with adrenal cushing syndrome by dexamethasone suppression test and 24 urine free cortisol test.
Other: Hormone study and Imaging study
  1. Blood (basal hormone and follow up hormone study)
  2. Imaging examination including computed tomography scan or magnetic resonance imaging
Adrenocortical carcinoma
patients who were diagnosed with adrenocortical carcinoma by imaging study or histologic exam
Other: Hormone study and Imaging study
  1. Blood (basal hormone and follow up hormone study)
  2. Imaging examination including computed tomography scan or magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in remission
Time Frame: Up to 10 years
Remission rate
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication of adrenal disease
Time Frame: Up to 10 years
all complications including deaths
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)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

December 31, 2027

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 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1801-010-911

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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