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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with Cushing's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exams and questionnaires | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| number of complications (hormonal and imaging results, quality of life) per patient (composite) | Evaluate the frequency of :
| from diagnosis until 3 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of Cushing's disease | 1 year after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Cushing 's disease
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Bertherat, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Hôpital Cochin | Paris | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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blood Urinary salivary
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |