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Natural History of NFAI: 10 Year Follow-up Results

NCT ID: NCT04616703

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adrenal Incidentaloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BMI < 25 kg/m2

Those with NFAT and BMI \< 25 kg/m2.

CT imaging

Intervention Type RADIATION

CT of abdomen

BMI 25-30 kg/m2

Those with NFAT and BMI 25-30 kg/m2.

CT imaging

Intervention Type RADIATION

CT of abdomen

BMI > 30 kg/m2

Those with NFAT and BMI \> 30 kg/m2.

CT imaging

Intervention Type RADIATION

CT of abdomen

Interventions

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CT imaging

CT of abdomen

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role collaborator

University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Mojca Jensterle

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mojca Jensterle, MD, PhD

Role: STUDY_DIRECTOR

University Medical Center Ljubljana, Slovenia

Locations

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Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Mojca Jensterle, MD, PhD

Role: CONTACT

[email protected]
003861 522 50 50

Facility Contacts

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Mojca Jensterle, MD, PhD

Role: primary

[email protected]
0o3861 522 50 5

Other Identifiers

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00000

Identifier Type: -

Identifier Source: org_study_id