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Completed

NCT Number: NCT02350153

Cushing´s Disease Epidemiology in Sweden

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.

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Key information

Conditions

Cushing Disease Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

About this study

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:

  • To study the influence of CD on myocardial infarction
  • To study the influence of CD on stroke
  • To study the influence of CD on cancer
  • To study the influence of CD on hip fracture risk
  • To study incidence and prevalence of CD in Sweden.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

National Swedish Study in Cushing´s Disease Incidence and Outcomes

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2015
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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