Natural History of NFAI: 10 Year Follow-up Results

Adrenal Incidentaloma Clinical Trial

Official title:

Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616703
• Other study ID #: 00000
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Adrenal Incidentaloma
• Adrenocortical Adenoma

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