NCT03474237

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress82%
Oct 2018Dec 2027

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 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

9.3 years

First QC Date

March 10, 2018

Last Update Submit

March 16, 2020

Conditions

Adrenal AdenomaCushing SyndromePheochromocytomaAdrenal IncidentalomaAdrenocortical CarcinomaPrimary Hyperaldosteronism

Keywords

algorithmsadrenal adenomacushing syndromepheochromocytomaadrenal incidentalomaadreocortical carcinomaprimary hyperaldosteronism

Outcome Measures

Primary Outcomes (1)

  • Number of participants in remission

    Remission rate

    Up to 10 years

Secondary Outcomes (1)

  • Complication of adrenal disease

    Up to 10 years

Study Arms (5)

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

Pheochromocytoma

patients who were diagnosed with pheochromocytoma biochemically or histologically

Other: Hormone study and Imaging study

Primary aldosteronism

patients who were diagnosed with primary aldosteronism by saline loading test

Other: Hormone study and Imaging study

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

Adrenocortical carcinoma

patients who were diagnosed with adrenocortical carcinoma by imaging study or histologic exam

Other: Hormone study and Imaging study

Interventions

Hormone study and Imaging studyOTHER

1. Blood (basal hormone and follow up hormone study) 2. Imaging examination including computed tomography scan or magnetic resonance imaging

Adrenal cushing syndromeAdrenocortical carcinomaNon-functioning adrenal incidentalomaPheochromocytomaPrimary aldosteronism

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

ACTH Syndrome, EctopicCushing SyndromePheochromocytomaAdrenal incidentalomaAdrenocortical CarcinomaHyperaldosteronism

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasmsAdrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex Diseases

Study Officials

  • Jung Hee Kim, M.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

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

October 1, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)