Cushing DiseaseNCT02350153
Cushing´s Disease Epidemiology in Sweden
An observational study of Cushing Disease, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Disease
- How many people
- 502 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with confirmed CD diagnosis in Sweden
Who may be able to join
- 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.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Cushing Disease
- Keywords
- Mortality, Morbidity, Incidence, Prevalence
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with verified Cushing's Disease | Patients with verified Cushing's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals
Measured: Assessed up to 20 years.
prevalence of Cushing's Disease in Sweden
Validation of Data obtained by The Swedish Board of Health and Welfare by reviewing all patients' journals
Measured: Assessed up to 20 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gudmundur Johannsson, Professor, Principal investigator, Vastra Gotaland Region, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350153
- Sponsor's protocol ID
- NSSCDIO
- Status last verified
- Apr 2019
- First submitted
- 5 Dec 2014
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Swedish Study in Cushing´s Disease Incidence and Outcomes
- ClinicalTrials.gov ID
- NCT02350153
- Acronym / sponsor ID
- NSSCDIO
- Conditions
- Cushing Disease
- Keywords
- Mortality, Morbidity, Incidence, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Sep 2013
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with verified Cushing's Disease | – | –Patients with verified Cushing's Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with confirmed CD diagnosis in Sweden
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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
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
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
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
incidence of Cushing's Disease in Sweden
Time frame: Assessed up to 20 years.
prevalence of Cushing's Disease in Sweden
Time frame: Assessed up to 20 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gudmundur Johannsson, Professor principal investigator
Vastra Gotaland Region, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Disease, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.