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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

Tracking Information
First Submitted Date December 5, 2014
First Posted Date January 29, 2015
Last Update Posted Date May 3, 2019
Study Start Date September 2013
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2015)
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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02350153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 23, 2015)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cushing´s Disease Epidemiology in Sweden
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All adult patients with confirmed CD diagnosis in Sweden
Condition Cushing Disease
Intervention Not Provided
Study Groups/Cohorts Patients with verified Cushing's Disease
Patients with verified Cushing's Disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2019)
502
Original Estimated Enrollment
 (submitted: January 23, 2015)
400
Actual Study Completion Date April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02350153
Other Study ID Numbers NSSCDIO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Vastra Gotaland Region
Study Sponsor Vastra Gotaland Region
Collaborators Not Provided
Investigators
Principal Investigator: Gudmundur Johannsson, Professor Vastra Gotaland Region, Sahlgrenska University Hospital
PRS Account Vastra Gotaland Region
Verification Date April 2019