NCT03297892

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 5, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

September 26, 2017

Last Update Submit

October 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • predictive factors of remission and recurrence

    between 1 January 1990 and 31 December 2015

Eligibility Criteria

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

All 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

October 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 5, 2017

Record last verified: 2017-09