Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 11:19 AM
Study NCT ID:
NCT04616703
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2020-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History of NFAI: 10 Year Follow-up Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C538238', 'term': 'Adrenal incidentaloma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097873', 'term': 'Postmortem Imaging'}], 'ancestors': [{'id': 'D001344', 'term': 'Autopsy'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'venous blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-10-29', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural History of NFAT - horomnal activity', 'timeFrame': '10 years', 'description': "To determine if and in how many pateints NFAI progressed to MACE.\n\nNFAI: 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.\n\nMACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is \\> 50 nmol/l."}, {'measure': 'Natural History of NFAT - growth', 'timeFrame': '10 years', 'description': 'To determine the change in size of NFAI on the CT scan (mm).'}, {'measure': 'Natural History of NFAT - BMI', 'timeFrame': '10 years', 'description': 'To determine the change in BMI and its correlation with outcome 1 and 2.\n\nWeight and height will be combined to report BMI in kg/m\\^2.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adrenal incidentaloma', 'BMI', 'NFAI', 'MACE', 'long term follow up', 'natural history'], 'conditions': ['Adrenal Incidentaloma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with diagnosisi of NFAI, hospitalized between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.\n\nExclusion Criteria:\n\n* age below 18 years\n* relatives reported that patient died in the time since hospitalization\n* patient did not want a follow up\n* patient did not attend follow up appointment\n* patient underwent adrenalectomy\n* misdiagnosis / missing main information in hospitalization record'}, 'identificationModule': {'nctId': 'NCT04616703', 'briefTitle': 'Natural History of NFAI: 10 Year Follow-up Results', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results', 'orgStudyIdInfo': {'id': '00000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BMI < 25 kg/m2', 'description': 'Those with NFAT and BMI \\< 25 kg/m2.', 'interventionNames': ['Radiation: CT imaging']}, {'label': 'BMI 25-30 kg/m2', 'description': 'Those with NFAT and BMI 25-30 kg/m2.', 'interventionNames': ['Radiation: CT imaging']}, {'label': 'BMI > 30 kg/m2', 'description': 'Those with NFAT and BMI \\> 30 kg/m2.', 'interventionNames': ['Radiation: CT imaging']}], 'interventions': [{'name': 'CT imaging', 'type': 'RADIATION', 'description': 'CT of abdomen', 'armGroupLabels': ['BMI 25-30 kg/m2', 'BMI < 25 kg/m2', 'BMI > 30 kg/m2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Mojca Jensterle, MD, PhD', 'role': 'CONTACT', 'email': 'mojca.jensterlesever@kclj.si', 'phone': '0o3861 522 50 5'}], 'facility': 'Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Mojca Jensterle, MD, PhD', 'role': 'CONTACT', 'email': 'mojca.jensterlesever@kclj.si', 'phone': '003861 522 50 50'}], 'overallOfficials': [{'name': 'Mojca Jensterle, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Ljubljana, Slovenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ljubljana, Faculty of Medicine', 'class': 'OTHER'}, {'name': 'University Rehabilitation Institute, Republic of Slovenia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Mojca Jensterle', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}