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Cushing's Disease Complications (COMPLICUSHING)

This study is currently recruiting participants.
Verified July 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02568982
First Posted: October 6, 2015
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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 Intervention
Cushing's Disease Other: Exams and questionnaires

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Remission rate of Cushing's disease [ Time Frame: 1 year after treatment ]

Biospecimen Retention:   Samples With DNA
blood Urinary salivary

Estimated Enrollment: 150
Study Start Date: September 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
"De Novo" 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)

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cushing 's disease
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568982


Contacts
Contact: Christelle-Nathalie Auger, Master +33 1 58 41 11 86 christelle.auger@cch.aphp.fr
Contact: Sophie Le Guen, Master +33 1 44 49 43 27 sophie.le-guen@nck.aphp.fr

Locations
France
AP-HP, Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Jerôme Bertherat, M.D., PhD    + 33 1 58 41 18 95    jerome.bertherat@cch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jerome Bertherat, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02568982     History of Changes
Other Study ID Numbers: P120132
First Submitted: July 20, 2015
First Posted: October 6, 2015
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cushing's disease
Quality of life
Metabolic
patients with Cushing's disease
cardiovascular
thromboembolic
bone complications

Additional relevant MeSH terms:
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site