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Natural History of NFAI: 10 Year Follow-up Results

U

University Medical Centre Ljubljana

Status

Unknown

Conditions

Adrenal Incidentaloma

Treatments

Radiation: CT imaging

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

65 participants in 3 patient groups

BMI < 25 kg/m2
Description:
Those with NFAT and BMI \< 25 kg/m2.
Treatment:
Radiation: CT imaging
BMI 25-30 kg/m2
Description:
Those with NFAT and BMI 25-30 kg/m2.
Treatment:
Radiation: CT imaging
BMI > 30 kg/m2
Description:
Those with NFAT and BMI \> 30 kg/m2.
Treatment:
Radiation: CT imaging

Trial contacts and locations

1

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Central trial contact

Mojca Jensterle, MD, PhD

Data sourced from clinicaltrials.gov

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