Cushing's DiseaseCOMPLICUSHINGNCT02568982
Cushing's Disease Complications
An observational study of Cushing's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Disease
- What is being tested?
- Exams and questionnaires
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2015to 20 Dec 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: Cushing 's disease
Who may be able to join
- Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease
Who cannot join
- other cause of Cushing's syndrome
- known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome)
- patient does not understand french
- life expectancy of less than 6 months
- pregnant women
- dependent patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease
This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.
Read the detailed description
At inclusion the following will be investigated and recorded :
- demographic and personal medical history.
- Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism.
- Current medical treatment.
- Physical examination.
- Assessment of basal 24hrs urinary cortisol and salivary cortisol.
- At baseline (i.e. before specific treatment of Cortisol excess):
- physical examination,
- routine biology,
- HbA1C, fasting glucose and oral glucose load,
- cholesterol, triglyceride, HDL \& LDL,
- coagulation and fibrinolysis investigation,
- 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
- EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US,
- ophthalmology examination,
- spine X-Ray, bone densitometry,
- QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
Every year during a 3 years follow-up the following will be investigated :
- Current medical treatment.
- Physical examination.
- Assessment of basal routine biology,
- HbA1C, fasting glucose,
- cholesterol, triglyceride, HDL \& LDL,
- coagulation and fibrinolysis investigation,
- 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
- EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US,
- ophthalmology examination, bone densitometry,
- QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
- Conditions
- Cushing's Disease
- Being tested
- Exams and questionnaires
- Keywords
- Cushing's disease, Quality of life, Metabolic, patients with Cushing's disease, cardiovascular, thromboembolic, bone complications
- 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.
Exams and questionnairesOther
Blood sample 24hrs urinary cortisol and salivary cortisol, urinary labstick test, EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US ophthalmology examination spine X-Ray bone densitometry QoL questionnaires (SF-36, QoLCushing, Beck BDI-II)
| Study group | Role | What they receive |
|---|---|---|
| patient with Cushing's disease | Not described Receives: Other: Exams and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of complications (hormonal and imaging results, quality of life) per patient (composite)
Evaluate the frequency of :
- metabolic complications (HbA1C, fasting glucose and oral glucose load, cholesterol, triglyceride, HDL \& LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test)
- cardiovascular thromboembolic complications (EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US)
- bone complications (spine X-Ray, bone densitometry)
- quality of life alteration measured by questionnaires (SF36, QoLCushing, Beck BDI-II)
Measured: from diagnosis until 3 years of treatment
Secondary outcomes (1)
Remission rate of Cushing's disease
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study start21 Sep 2015
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jerome Bertherat, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568982
- Sponsor's protocol ID
- P120132
- Acronym
- COMPLICUSHING
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2015
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease
- ClinicalTrials.gov ID
- NCT02568982
- Acronym / sponsor ID
- COMPLICUSHING / P120132
- Conditions
- Cushing's Disease
- Keywords
- Cushing's disease, Quality of life, Metabolic, patients with Cushing's disease, cardiovascular, thromboembolic, bone complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Sep 2015 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 6 Oct 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.
This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.
Detailed description
At inclusion the following will be investigated and recorded :
- demographic and personal medical history.
- Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism.
- Current medical treatment.
- Physical examination.
- Assessment of basal 24hrs urinary cortisol and salivary cortisol.
- At baseline (i.e. before specific treatment of Cortisol excess):
- physical examination,
- routine biology,
- HbA1C, fasting glucose and oral glucose load,
- cholesterol, triglyceride, HDL \& LDL,
- coagulation and fibrinolysis investigation,
- 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
- EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US,
- ophthalmology examination,
- spine X-Ray, bone densitometry,
- QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
Every year during a 3 years follow-up the following will be investigated :
- Current medical treatment.
- Physical examination.
- Assessment of basal routine biology,
- HbA1C, fasting glucose,
- cholesterol, triglyceride, HDL \& LDL,
- coagulation and fibrinolysis investigation,
- 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
- EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US,
- ophthalmology examination, bone densitometry,
- QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with Cushing's disease | – | Other: Exams and questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cushing 's disease
Key inclusion criteria (1 listed)
- Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease
Key exclusion criteria (6 listed)
- other cause of Cushing's syndrome
- known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome)
- patient does not understand french
- life expectancy of less than 6 months
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exams and questionnairesBlood sample 24hrs urinary cortisol and salivary cortisol, urinary labstick test, EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US ophthalmology examination spine X-Ray bone densitometry QoL questionnaires (SF-36, QoLCushing, Beck BDI-II) | Other | patient with Cushing's disease |
Primary outcome
number of complications (hormonal and imaging results, quality of life) per patient (composite)
Time frame: from diagnosis until 3 years of treatment
Evaluate the frequency of : * metabolic complications (HbA1C, fasting glucose and oral glucose load, cholesterol, triglyceride, HDL \& LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test) * cardiovascular thromboembolic complications (EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US) * bone complications (spine X-Ray, bone densitometry) * quality of life alteration measured by questionnaires (SF36, QoLCushing, Beck BDI-II)
1 secondary outcome
Remission rate of Cushing's disease
Time frame: 1 year after treatment
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 30 Mar 2026.
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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.
Jerome Bertherat, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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 30 Mar 2026. 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 France. 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?
number of complications (hormonal and imaging results, quality of life) per patient (composite) (time frame: from diagnosis until 3 years of treatment). 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 30 Mar 2026.