Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 2:25 PM
Study NCT ID:
NCT04917757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2021-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C538238', 'term': 'Adrenal incidentaloma'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fassnacht_m@ukw.de', 'phone': '4993120139021', 'title': 'Prof Dr. Martin Fassnacht', 'organization': 'University Hospital Würzburg'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of primary diagnosis of the adrenal incidentaloma until the date of death or last follow-up (data lock December 31, 2018). Median follow-up duration was 7.0 years.', 'description': 'Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death.\n\nTime frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-functioning Adenoma', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L', 'otherNumAtRisk': 2002, 'deathsNumAtRisk': 2089, 'otherNumAffected': 724, 'seriousNumAtRisk': 1892, 'deathsNumAffected': 143, 'seriousNumAffected': 145}, {'id': 'EG001', 'title': 'Adenoma With Possible Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L', 'otherNumAtRisk': 1250, 'deathsNumAtRisk': 1320, 'otherNumAffected': 547, 'seriousNumAtRisk': 1208, 'deathsNumAffected': 168, 'seriousNumAffected': 130}, {'id': 'EG002', 'title': 'Adenoma With Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: \\> 138 nmol/L', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 247, 'otherNumAffected': 123, 'seriousNumAtRisk': 225, 'deathsNumAffected': 41, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Dylipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2002, 'numAffected': 724}, {'groupId': 'EG001', 'numAtRisk': 1250, 'numAffected': 547}, {'groupId': 'EG002', 'numAtRisk': 232, 'numAffected': 123}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'MACE', 'notes': 'major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1892, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 1208, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 225, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2089', 'groupId': 'OG000'}, {'value': '1320', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-functioning Adenoma', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L'}, {'id': 'OG001', 'title': 'Adenoma With Possible Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L'}, {'id': 'OG002', 'title': 'Adenoma With Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: \\> 138 nmol/L'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of primary diagnosis of the adrenal incidentaloma to the date of death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.', 'description': 'death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1892', 'groupId': 'OG000'}, {'value': '1208', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-functioning Adenoma', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L'}, {'id': 'OG001', 'title': 'Adenoma With Possible Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L'}, {'id': 'OG002', 'title': 'Adenoma With Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: \\> 138 nmol/L'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of primary diagnosis of the adrenal incidentaloma to the date of the first CV event or death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.', 'description': 'Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of analyzed patients is slightly smaller than the total cohort, because for some patients no data on cardiovascular outcome were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-functioning Adenoma', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L'}, {'id': 'FG001', 'title': 'Adenoma With Possible Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L'}, {'id': 'FG002', 'title': 'Adenoma With Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: \\> 138 nmol/L'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2089'}, {'groupId': 'FG001', 'numSubjects': '1320'}, {'groupId': 'FG002', 'numSubjects': '247'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2089'}, {'groupId': 'FG001', 'numSubjects': '1320'}, {'groupId': 'FG002', 'numSubjects': '247'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2089', 'groupId': 'BG000'}, {'value': '1320', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}, {'value': '3656', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-functioning Adenoma', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L'}, {'id': 'BG001', 'title': 'Adenoma With Possible Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L'}, {'id': 'BG002', 'title': 'Adenoma With Autonomous Cortisol Secretion', 'description': 'cortisol values after an overnight 1 mg dexamethasone suppression test: \\> 138 nmol/L'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1404', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '2264', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '685', 'groupId': 'BG000'}, {'value': '594', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '1392', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '67'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '67'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '70'}, {'value': '61', 'groupId': 'BG003', 'lowerLimit': '53', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1321', 'groupId': 'BG000'}, {'value': '860', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '2350', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '768', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '1306', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2011', 'groupId': 'BG000'}, {'value': '1271', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}, {'value': '3520', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1935', 'groupId': 'BG000'}, {'value': '1222', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}, {'value': '3386', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'adenoma diameter', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '25'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '33'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '37'}, {'value': '22', 'groupId': 'BG003', 'lowerLimit': '15', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-04', 'size': 157698, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-19T09:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3656}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2021-06-01', 'resultsFirstSubmitDate': '2023-02-04', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-09-29', 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From date of primary diagnosis of the adrenal incidentaloma to the date of death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.', 'description': 'death'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Morbidity', 'timeFrame': 'From date of primary diagnosis of the adrenal incidentaloma to the date of the first CV event or death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.', 'description': 'Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adrenal Incidentaloma']}, 'referencesModule': {'references': [{'pmid': '35533704', 'type': 'RESULT', 'citation': 'Deutschbein T, Reimondo G, Di Dalmazi G, Bancos I, Patrova J, Vassiliadi DA, Nekic AB, Debono M, Lardo P, Ceccato F, Petramala L, Prete A, Chiodini I, Ivovic M, Pazaitou-Panayiotou K, Alexandraki KI, Hanzu FA, Loli P, Yener S, Langton K, Spyroglou A, Kocjan T, Zacharieva S, Valdes N, Ambroziak U, Suzuki M, Detomas M, Puglisi S, Tucci L, Delivanis DA, Margaritopoulos D, Dusek T, Maggio R, Scaroni C, Concistre A, Ronchi CL, Altieri B, Mosconi C, Diamantopoulos A, Iniguez-Ariza NM, Vicennati V, Pia A, Kroiss M, Kaltsas G, Chrisoulidou A, Marina LV, Morelli V, Arlt W, Letizia C, Boscaro M, Stigliano A, Kastelan D, Tsagarakis S, Athimulam S, Pagotto U, Maeder U, Falhammar H, Newell-Price J, Terzolo M, Fassnacht M. Age-dependent and sex-dependent disparity in mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: an international, retrospective, cohort study. Lancet Diabetes Endocrinol. 2022 Jul;10(7):499-508. doi: 10.1016/S2213-8587(22)00100-0. Epub 2022 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to assess mortality and cardiovascular events potentially linked to cortisol excess in patients with adrenal incidentalomas stratified by cortisol values following the 1-mg overnight dexamethasone test.', 'detailedDescription': 'The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with adrenal incidentaloma', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age ≥18 years\n* adrenal incidentaloma (≥ 1cm) detected by cross-sectional imaging between January 1, 1996 and December 31, 2015\n* imaging characteristics suggestive for an adrenal adenoma or excluded malignancy by follow-up imaging\n* availability of a 1 mg dexamethasone test result\n* follow-up data on living status and occurrence of cardiovascular events\n* follow-up duration of at least 36 months.\n\nExclusion Criteria:\n\n* proven pheochromocytoma, primary hyperaldosteronism or adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome\n* clinical features suggestive for overt Cushing's syndrome; urinary free cortisol (UFC) ≥ 2-fold higher than the upper limit of normal of the local assay\n* any active malignancy (including adrenocortical cancer) at the time of primary diagnosis"}, 'identificationModule': {'nctId': 'NCT04917757', 'acronym': 'NAPACA', 'briefTitle': 'Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry', 'orgStudyIdInfo': {'id': 'NAPACA-Outcome'}}, 'armsInterventionsModule': {'interventions': [{'name': '1mg Dexamethasone test', 'type': 'DIAGNOSTIC_TEST', 'description': 'For each patient a 1mg dexamethasone test has been performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Turin', 'country': 'Italy', 'facility': 'University Turin', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Martin Fassnacht, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not yet decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Network for the Study of Adrenal Tumors', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Dept. of Endocrinology and Diabetes', 'investigatorFullName': 'Martin Fassnacht', 'investigatorAffiliation': 'Wuerzburg University Hospital'}}}}