NCT02350153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 3, 2019

Status Verified

April 1, 2019

Enrollment Period

5.6 years

First QC Date

December 5, 2014

Last Update Submit

April 30, 2019

Conditions

Keywords

MortalityMorbidityIncidencePrevalence

Outcome Measures

Primary Outcomes (1)

  • Mortality

    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 Outcomes (6)

  • influence of Cushing's Disease on myocardial infarction

    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

    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

    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

    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

    Assessed up to 20 years.

  • +1 more secondary outcomes

Study Arms (1)

Patients with verified Cushing's Disease

Patients with verified Cushing's Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients with confirmed CD diagnosis in Sweden

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Gudmundur Johannsson, Professor

    Vastra Gotaland Region, Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

January 29, 2015

Study Start

September 1, 2013

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 3, 2019

Record last verified: 2019-04

Locations