The Factors Associated With the Recurrence in Patients With Cushing Disease

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02233335
Collaborator
(none)
42
1
11
3.8

Study Details

Study Description

Brief Summary

Cushing syndrome refers the manifestations induced by chronic glucocorticoid excess and may arise from various causes. Iatrogenic Cushing syndrome accounts for most patients, when they are given exogenous glucocorticoid treatment. In contrast, spontaneous Cushing syndrome results from endogenous glucocorticoid over-secretion. Although Cushing disease is rare, it is the most common cause of spontaneous Cushing syndrome. The patient with Cushing disease has a pituitary corticotroph adenoma, which overproduces adrenocorticotropic hormone (ACTH). ACTH then stimulates adrenal gland to over-secret glucocorticoid. Patients with untreated Cushing disease were shown to have poor prognosis, estimated a 5-year survival rate of 50%. The first line treatment is tumor resection. Other managements include radiotherapy, medication and bilateral adrenalectomy. The initial remission rate is high (66-90%). However, some patients encounter with disease recurrence during follow-up.

The aim of this study is to clarify the factors associated with the recurrence after treatment. In this study, we will review the patients with Cushing disease thoroughly and analyze associated predisposing factors. These risk factors can remind the clinical physician to early detect the recurrent disease in these patients, and further prevent morbidity and mortality in their later lives.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    42 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Factors Associated With the Recurrence in Patients With Cushing Disease
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with disease persistence or recurrence after surgery, which was determined by clinical symptoms, biochemical lab, dynamic test and image study [participants were followed at 3 months after treatment for short-term outcome measure and followed until the last hospital visit, an average of 4.7 years, for long-term outcome measure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosed Cushing's disease
    Exclusion Criteria:
    • Already received treatment in other hospital

    • Ectopic Cushing's syndrome

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Chair: Tien-Chun Chang, M.D., Ph.D., Department of Internal Medicine, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02233335
    Other Study ID Numbers:
    • 201305026RINC
    First Posted:
    Sep 8, 2014
    Last Update Posted:
    Sep 8, 2014
    Last Verified:
    Sep 1, 2014

    Study Results

    No Results Posted as of Sep 8, 2014