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The Factors Associated With the Recurrence in Patients With Cushing Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02233335
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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
Cushing Disease

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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 : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine





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 [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Cushing's disease who presented to the National Taiwan University Hospital between 1992 and 2011
Criteria

Inclusion Criteria:

  • Clinical diagnosed Cushing's disease

Exclusion Criteria:

  • Already received treatment in other hospital
  • Ectopic Cushing's syndrome

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): NCT02233335


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Tien-Chun Chang, M.D., Ph.D. Department of Internal Medicine, National Taiwan University Hospital

Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02233335    
Other Study ID Numbers: 201305026RINC
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Recurrence
Disease Attributes
Pathologic Processes
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