NCT02233335

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

August 27, 2014

Last Update Submit

September 2, 2014

Conditions

Outcome Measures

Primary Outcomes (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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Cushing's disease who presented to the National Taiwan University Hospital between 1992 and 2011

You may qualify if:

  • Clinical diagnosed Cushing's disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (10)

  • PLOTZ CM, KNOWLTON AI, RAGAN C. The natural history of Cushing's syndrome. Am J Med. 1952 Nov;13(5):597-614. doi: 10.1016/0002-9343(52)90027-2. No abstract available.

    PMID: 12996538BACKGROUND
  • Etxabe J, Vazquez JA. Morbidity and mortality in Cushing's disease: an epidemiological approach. Clin Endocrinol (Oxf). 1994 Apr;40(4):479-84. doi: 10.1111/j.1365-2265.1994.tb02486.x.

    PMID: 8187313BACKGROUND
  • Swearingen B, Biller BM, Barker FG 2nd, Katznelson L, Grinspoon S, Klibanski A, Zervas NT. Long-term mortality after transsphenoidal surgery for Cushing disease. Ann Intern Med. 1999 May 18;130(10):821-4. doi: 10.7326/0003-4819-130-10-199905180-00015.

    PMID: 10366371BACKGROUND
  • Lindholm J, Juul S, Jorgensen JO, Astrup J, Bjerre P, Feldt-Rasmussen U, Hagen C, Jorgensen J, Kosteljanetz M, Kristensen L, Laurberg P, Schmidt K, Weeke J. Incidence and late prognosis of cushing's syndrome: a population-based study. J Clin Endocrinol Metab. 2001 Jan;86(1):117-23. doi: 10.1210/jcem.86.1.7093.

    PMID: 11231987BACKGROUND
  • Hammer GD, Tyrrell JB, Lamborn KR, Applebury CB, Hannegan ET, Bell S, Rahl R, Lu A, Wilson CB. Transsphenoidal microsurgery for Cushing's disease: initial outcome and long-term results. J Clin Endocrinol Metab. 2004 Dec;89(12):6348-57. doi: 10.1210/jc.2003-032180.

    PMID: 15579802BACKGROUND
  • Dekkers OM, Biermasz NR, Pereira AM, Roelfsema F, van Aken MO, Voormolen JH, Romijn JA. Mortality in patients treated for Cushing's disease is increased, compared with patients treated for nonfunctioning pituitary macroadenoma. J Clin Endocrinol Metab. 2007 Mar;92(3):976-81. doi: 10.1210/jc.2006-2112. Epub 2007 Jan 2.

    PMID: 17200171BACKGROUND
  • Clayton RN, Raskauskiene D, Reulen RC, Jones PW. Mortality and morbidity in Cushing's disease over 50 years in Stoke-on-Trent, UK: audit and meta-analysis of literature. J Clin Endocrinol Metab. 2011 Mar;96(3):632-42. doi: 10.1210/jc.2010-1942. Epub 2010 Dec 30.

    PMID: 21193542BACKGROUND
  • Hassan-Smith ZK, Sherlock M, Reulen RC, Arlt W, Ayuk J, Toogood AA, Cooper MS, Johnson AP, Stewart PM. Outcome of Cushing's disease following transsphenoidal surgery in a single center over 20 years. J Clin Endocrinol Metab. 2012 Apr;97(4):1194-201. doi: 10.1210/jc.2011-2957. Epub 2012 Jan 25.

    PMID: 22278423BACKGROUND
  • Atkinson AB, Kennedy A, Wiggam MI, McCance DR, Sheridan B. Long-term remission rates after pituitary surgery for Cushing's disease: the need for long-term surveillance. Clin Endocrinol (Oxf). 2005 Nov;63(5):549-59. doi: 10.1111/j.1365-2265.2005.02380.x.

    PMID: 16268808BACKGROUND
  • Pikkarainen L, Sane T, Reunanen A. The survival and well-being of patients treated for Cushing's syndrome. J Intern Med. 1999 May;245(5):463-8. doi: 10.1046/j.1365-2796.1999.00483.x.

    PMID: 10363746BACKGROUND

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Tien-Chun Chang, M.D., Ph.D.

    Department of Internal Medicine, National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2014

First Posted

September 8, 2014

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations