Clinical trial NCT02350153: Cushing´s Disease Epidemiology in Sweden
Official title: National Swedish Study in Cushing´s Disease Incidence and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cushing Disease
Keywords: Mortality
Morbidity
Incidence
Prevalence
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2015-01-29
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with confirmed CD diagnosis in Sweden

Brief summary: The purpose of this study is to study since 1987 all patients diagnosed with CD in Sweden and determine their outcomes including mortality. A secondary objective is to focus on patients in remission and identify determinants of their different outcomes.

Detailed description: This study is a retrospective nationwide study of all patients in Sweden with diagnosis CD between 1987 and 2013 were baseline data at diagnosis, information about the different treatments and follow-up data is going to be obtained by reviewing patients' medical journals. This information as well as the exact diagnose criteria for each patient are going to be extracted by Endocrinologists in all University Hospitals in Sweden. An expert group at the Sahlgrenska University Hospital in Gothenburg will put together the data.By the use of the Swedish Personal Number, the investigators are going to obtain information about both patients' and background population co-morbidities which have been collected in the different Swedish Registers.

Primary aim:

To study mortality of CD in Sweden.

Secondary aims:

1. To study the influence of CD on myocardial infarction
2. To study the influence of CD on stroke
3. To study the influence of CD on cancer
4. To study the influence of CD on hip fracture risk
5. To study incidence and prevalence of CD in Sweden.

Eligibility criteria: Inclusion Criteria:

* All patients registered with Cushing's Disease in Sweden since 1987 in the statistical database for in- and out-patients, at the Swedish National Board of Health and Welfare will be included in the study.

Exclusion Criteria:

* No

Primary outcomes:
measure: Mortality
timeFrame: From date of diagnosis until the last day of December 2014 or date of death from any cause, whichever came first, assessed up to 20 years.
Secondary outcomes:
measure: influence of Cushing's Disease on myocardial infarction
timeFrame: From date of diagnosis until the last day of December 2014 or date of death from any cause, whichever came first, assessed up to 20 years
measure: influence of Cushing's Disease on stroke
timeFrame: From date of diagnosis until the last day of December 2014 or date of death from any cause, whichever came first, assessed up to 20 years
measure: influence of Cushing's Disease on cancer
timeFrame: From date of diagnosis until the last day of December 2014 or date of death from any cause, whichever came first, assessed up to 20 years
measure: influence of Cushing's Disease on hip fracture risk
timeFrame: From date of diagnosis until the last day of December 2014 or date of death from any cause, whichever came first, assessed up to 20 years
measure: incidence of Cushing's Disease in Sweden
timeFrame: Assessed up to 20 years.
measure: prevalence of Cushing's Disease in Sweden
timeFrame: Assessed up to 20 years.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Vastra Gotaland Region
Study officials:
affiliation: Vastra Gotaland Region, Sahlgrenska University Hospital
name: Gudmundur Johannsson, Professor
role: PRINCIPAL_INVESTIGATOR
References: