NCT02568982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

July 20, 2015

Last Update Submit

March 25, 2026

Conditions

Cushing's Disease

Keywords

Cushing's diseaseQuality of lifeMetabolicpatients with Cushing's diseasecardiovascularthromboembolicbone complications

Outcome Measures

Primary Outcomes (1)

  • 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)

    from diagnosis until 3 years of treatment

Secondary Outcomes (1)

  • Remission rate of Cushing's disease

    1 year after treatment

Study Arms (1)

patient with Cushing's disease

Other: Exams and questionnaires

Interventions

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)

patient with Cushing's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cushing 's disease

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Hôpital Cochin

Paris, Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood Urinary salivary

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jerome Bertherat, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

October 6, 2015

Study Start

September 21, 2015

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

FR(1)