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Trial record 43 of 67 for:    "Adrenocortical carcinoma"

A Prospective Cohort Study for Patients With Adrenal Diseases

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ClinicalTrials.gov Identifier: NCT03474237
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jung Hee Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment
Adrenal Adenoma Cushing Syndrome Pheochromocytoma Adrenal Incidentaloma Adrenocortical Carcinoma Primary Hyperaldosteronism Other: Hormone study and Imaging study

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
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study for Patients With Adrenal Diseases
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027


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




Primary Outcome Measures :
  1. Number of participants in remission [ Time Frame: Up to 10 years ]
    Remission rate


Secondary Outcome Measures :
  1. Complication of adrenal disease [ Time Frame: Up to 10 years ]
    all complications including deaths



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474237


Contacts
Contact: Jung Hee Kim, MD 82-2-2072-4073 jhkxingfu@gmail.com

Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jung Hee Kim, M.D Seoul National University Hospital

Responsible Party: Jung Hee Kim, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03474237     History of Changes
Other Study ID Numbers: 1801-010-911
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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, Seoul National University Hospital:
algorithms
adrenal adenoma
cushing syndrome
pheochromocytoma
adrenal incidentaloma
adreocortical carcinoma
primary hyperaldosteronism

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Adenoma
Pheochromocytoma
Cushing Syndrome
Hyperaldosteronism
Adrenocortical Adenoma
Adrenal Gland Neoplasms
Adrenal Gland Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adrenocortical Hyperfunction
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Adrenal Cortex Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Hormones
Epinephrine
Racepinephrine
Epinephryl borate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs