Cushing´s Disease Epidemiology in Sweden

April 30, 2019 updated by: Vastra Gotaland Region

National Swedish Study in Cushing´s Disease Incidence and Outcomes

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Vastra Gotaland Region
      • Gothenburg, Vastra Gotaland Region, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients with confirmed CD diagnosis in Sweden

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with verified Cushing's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
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)
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
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
Assessed up to 20 years.
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
Assessed up to 20 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Gudmundur Johannsson, Professor, Vastra Gotaland Region, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSSCDIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cushing Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe