Health Status of the Patients Followed for a Disease of Cushing in the Region Large-West of 1990 to 2015

Cushing Disease Clinical Trial

— CUSHING  

Official title:

Etat de santé Des Patients Suivis Pour Une Maladie de Cushing Dans la région Grand-Ouest de 1990 à 2015

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03297892
• Other study ID #: CUSHING RB (15.217)
• Status: Not yet recruiting
• Phase: N/A
• First received: September 26, 2017
• Last updated: October 3, 2017
• Start date: October 2017
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cushing's disease is a rare disease that can reduce patients' expectations or quality of life, and for which predictive factors for cardiovascular mortality and recurrence are not well defined.

The primary objective is to determine the rates of remission and recurrence of patients with Cushing's disease diagnosed between 1990 and 2015 in the French region of the West (Angers, Brest, Nantes, Rennes, Poitiers , Tours) focusing on remission particularly at two periods : that after the first pituitary surgery and that on the day of the last news.

The secondary objective is to study the possible prediction of clinical and biological data perioperative of remission and recurrence during follow-up.

Description:

Investigators are interested in the prevalence of complications of the pathology (cardiovascular, metabolic, neuropsychological, infectious, rheumatological, etc.) within this cohort, the mortality rate, the rate of remission and recurrence and the quality of life history using the history of patient illness and a questionnaire.

All patients over the age of 18 years at the time of inclusion, formerly or currently being monitored for Cushing's disease diagnosed between January 1, 1990 and December 31, 2015, in one of the six university centers in the West part of France can be included.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients over the age of 18 at inclusion,

• formerly or currently being followed for Cushing's disease diagnosed between 1 January 1990 and 31 December 2015 in one of the six university centers in the French West.

Exclusion Criteria:

• Minor patients,

• patients with a pathologic analysis in favor of a mixed secretion adenoma (positive immunohistochemical analysis for ACTH and another hormone of the anterior pituitary).

• patients who have undergone a pathologic diagnosis of "adenoma to ACTH" without clinical-biological Cushing syndrome, ie silent adenoma

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing Disease
• Pituitary ACTH Hypersecretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates de remission and recurrence after the first surgery	rate of postoperative 3-month remission and rate of recurrence after the first surgery	between 1 January 1990 and 31 December 2015
Secondary	predictive factors of remission and recurrence	To study the significance link between the peri-operative clinical and biological characteristics and remission on the one hand and the risk of recurrence after first pituitary surgery on the other hand.	between 1 January 1990 and 31 December 2015