Cushing´s Disease Epidemiology in Sweden

Cushing Disease Clinical Trial

Official title:

National Swedish Study in Cushing´s Disease Incidence and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350153
• Other study ID #: NSSCDIO
• Status: Completed
• Start date: September 2013
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing Disease
• Pituitary ACTH Hypersecretion

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Vastra Gotaland Region

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	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)	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	influence of Cushing's Disease on myocardial infarction	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)	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	influence of Cushing's Disease on stroke	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)	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	influence of Cushing's Disease on cancer	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)	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	influence of Cushing's Disease on hip fracture risk	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)	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	incidence of Cushing's Disease in Sweden	Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals	Assessed up to 20 years.
Secondary	prevalence of Cushing's Disease in Sweden	Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals	Assessed up to 20 years.