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Enrolling by invitationNCT03474237Updated Mar 18, 2020

A Prospective Cohort Study for Patients With Adrenal Diseases

An observational study in Adrenal Adenoma, Cushing Syndrome and Pheochromocytoma, sponsored by Seoul National University Hospital. Enrolling by invitation at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adrenal Adenoma
  • Cushing Syndrome
  • Pheochromocytoma
  • Adrenal Incidentaloma
  • Adrenocortical Carcinoma
  • Primary Hyperaldosteronism

Keywords

  • algorithms
  • adrenal adenoma
  • cushing syndrome
  • pheochromocytoma
  • adrenal incidentaloma
  • adreocortical carcinoma
  • primary hyperaldosteronism
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherHormone study and Imaging study

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

05

What researchers measure

Primary outcomes

  1. Number of participants in remission

    Remission rate

    Time frame: Up to 10 years

Secondary outcomes

  1. Complication of adrenal disease

    all complications including deaths

    Time frame: Up to 10 years

06

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03474237
Lead sponsor
Seoul National University Hospital
Responsible party
Jung Hee Kim (Principal Investigator, Seoul National University Hospital) — Principal investigator
First posted
Mar 22, 2018
Start date
Oct 1, 2018
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 18, 2020

Study contacts

Jung Hee Kim, M.D
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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