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Cushing´s Disease Epidemiology in Sweden

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ClinicalTrials.gov Identifier: NCT02350153
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Cushing Disease

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.

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Study Type : Observational
Actual Enrollment : 502 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: National Swedish Study in Cushing´s Disease Incidence and Outcomes
Study Start Date : September 2013
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with verified Cushing's Disease
Patients with verified Cushing's Disease



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients with confirmed CD diagnosis in Sweden
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350153


Locations
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Sweden
Sahlgrenska University Hospital
Gothenburg, Vastra Gotaland Region, Sweden, 413 45
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Gudmundur Johannsson, Professor Vastra Gotaland Region, Sahlgrenska University Hospital

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02350153     History of Changes
Other Study ID Numbers: NSSCDIO
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vastra Gotaland Region:
Mortality
Morbidity
Incidence
Prevalence
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site