Cushing´s Disease Epidemiology in Sweden

Completed

• Conditions: Cushing Disease

• Registration Number: NCT02350153
• Lead Sponsor: Vastra Gotaland Region

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-29
• Status Verified: 2019-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	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.	If event (death) has been occured during the observation period. Data obtained by the Swedish Cause Of Death Register (Swedish Board of Health and Welfare)

Secondary Outcome Measures

Name	Time	Method
prevalence of Cushing's Disease in Sweden	Assessed up to 20 years.	Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals
influence of Cushing's Disease on myocardial infarction	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	If event (myocardial infarction) has been occured during the observation period.Data obtained by the Swedish Register of In- and Out-patient Diagnoses (Swedish Board of Health and Welfare)
incidence of Cushing's Disease in Sweden	Assessed up to 20 years.	Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals
influence of Cushing's Disease on stroke	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	If event (stroke) has been occured during the observation period.Data obtained by the Swedish Register of In- and Out-patient Diagnoses (Swedish Board of Health and Welfare)
influence of Cushing's Disease on hip fracture risk	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	If event (hip fracture) has been occured during the observation period.Data obtained by the Swedish Register of Hip Fractures (Swedish Board of Health and Welfare)
influence of Cushing's Disease on cancer	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	If event (cancer) has been occured during the observation period.Data obtained by the Swedish Register of Cancer Diagnoses (Swedish Board of Health and Welfare)

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Vastra Gotaland Region, Sweden