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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04616703
Other study ID # 00000
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 1, 2020

Study information

Verified date October 2020
Source University Medical Centre Ljubljana
Contact Mojca Jensterle, MD, PhD
Phone 003861 522 50 50
Email mojca.jensterlesever@kclj.si
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.


Description:

After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI < 25 kg/m2, 25-30 kg/m2 and > 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date December 1, 2020
Est. primary completion date November 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. Exclusion Criteria: - age below 18 years - relatives reported that patient died in the time since hospitalization - patient did not want a follow up - patient did not attend follow up appointment - patient underwent adrenalectomy - misdiagnosis / missing main information in hospitalization record

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
CT imaging
CT of abdomen

Locations

Country Name City State
Slovenia Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia Ljubljana

Sponsors (3)

Lead Sponsor Collaborator
University Medical Centre Ljubljana University of Ljubljana, Faculty of Medicine, University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Natural History of NFAT - horomnal activity To determine if and in how many pateints NFAI progressed to MACE.
NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is < 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded.
MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is > 50 nmol/l.
10 years
Primary Natural History of NFAT - growth To determine the change in size of NFAI on the CT scan (mm). 10 years
Primary Natural History of NFAT - BMI To determine the change in BMI and its correlation with outcome 1 and 2.
Weight and height will be combined to report BMI in kg/m^2.
10 years
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