Clinical Trial: Cushing´s Disease Epidemiology in Sweden

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: National Swedish Study in Cushing´s Disease Incidence and Outcomes

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 Summary:

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.

Sponsor: Vastra Gotaland Region

Current Primary Outcome: Mortality [ Time Frame: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• influence of Cushing's Disease on myocardial infarction [ Time Frame: 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)
• influence of Cushing's Disease on stroke [ Time Frame: 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 cancer [ Time Frame: 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)
• influence of Cushing's Disease on hip fracture risk [ Time Frame: 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)
• incidence of Cushing's Disease in Sweden [ Time Frame: Assessed up to 20 years. ]
  Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals
• prevalence of Cushing's Disease in Sweden [ Time Frame: Assessed up to 20 years. ]
  Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals

Original Secondary Outcome: Same as current

Information By: Vastra Gotaland Region

Dates:
Date Received: December 5, 2014
Date Started: September 2013
Date Completion: September 2017
Last Updated: May 9, 2017
Last Verified: May 2017