COMPLICUSHING: Cushing's Disease Complications

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02568982

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Cushing's Disease	Other: Exams and questionnaires

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

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease

Actual Study Start Date :

Sep 21, 2015

Actual Primary Completion Date :

Dec 20, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
patient with Cushing's disease	Other: Exams and questionnaires 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)

Arm

Intervention/Treatment

patient with Cushing's disease

Other: Exams and questionnaires

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)

Outcome Measures

Primary Outcome Measures

number of complications (hormonal and imaging results, quality of life) per patient (composite) [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)

Secondary Outcome Measures

Remission rate of Cushing's disease [1 year after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease

Exclusion Criteria:

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