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| Name | Class |
|---|---|
| European Network for the Study of Adrenal Tumors | OTHER_GOV |
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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.
The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1mg Dexamethasone test | Diagnostic Test | For each patient a 1mg dexamethasone test has been performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | death | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Morbidity | Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with adrenal incidentaloma
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| Name | Affiliation | Role |
|---|---|---|
| Martin Fassnacht, MD | Wuerzburg University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Würzburg | Würzburg | 97080 | Germany | |||
| University Turin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35533704 | Result | 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. |
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not yet decided.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-functioning Adenoma | cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L |
| FG001 | Adenoma With Possible Autonomous Cortisol Secretion | cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L |
| FG002 | Adenoma With Autonomous Cortisol Secretion | cortisol values after an overnight 1 mg dexamethasone suppression test: > 138 nmol/L |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-functioning Adenoma | cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L |
| BG001 | Adenoma With Possible Autonomous Cortisol Secretion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | death | Posted | Count of Participants | Participants | 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. |
|
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.
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.
Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-functioning Adenoma | cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MACE | Cardiac disorders | Systematic Assessment | major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dylipidemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dr. Martin Fassnacht | University Hospital Würzburg | 4993120139021 | fassnacht_m@ukw.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2018 | Nov 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C538238 | Adrenal incidentaloma |
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| Turin |
| Italy |
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
| BG002 | Adenoma With Autonomous Cortisol Secretion | cortisol values after an overnight 1 mg dexamethasone suppression test: > 138 nmol/L |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| adenoma diameter | Median | Inter-Quartile Range | mm |
|
cortisol values after an overnight 1 mg dexamethasone suppression test: > 138 nmol/L |
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| Secondary | Cardiovascular Morbidity | Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism) | The number of analyzed patients is slightly smaller than the total cohort, because for some patients no data on cardiovascular outcome were available. | Posted | Count of Participants | Participants | 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. |
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|
|
| 143 |
| 2,089 |
| 145 |
| 1,892 |
| 724 |
| 2,002 |
| EG001 | Adenoma With Possible Autonomous Cortisol Secretion | cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L | 168 | 1,320 | 130 | 1,208 | 547 | 1,250 |
| EG002 | Adenoma With Autonomous Cortisol Secretion | cortisol values after an overnight 1 mg dexamethasone suppression test: > 138 nmol/L | 41 | 247 | 22 | 225 | 123 | 232 |
|
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