The Factors Associated With the Recurrence in Patients With Cushing Disease

Cushing Disease Clinical Trial

Official title:

The Factors Associated With the Recurrence in Patients With Cushing Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233335
• Other study ID #: 201305026RINC
• Status: Completed
• Phase: N/A
• First received: August 27, 2014
• Last updated: September 2, 2014
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosed Cushing's disease

Exclusion Criteria:

• Already received treatment in other hospital

• Ectopic Cushing's syndrome

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

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. Epub 2007 Jan 2. — View Citation

Etxabe J, Vazquez JA. Morbidity and mortality in Cushing's disease: an epidemiological approach. Clin Endocrinol (Oxf). 1994 Apr;40(4):479-84. — View Citation

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. — View Citation

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. — View Citation

Lindholm J, Juul S, Jørgensen JO, Astrup J, Bjerre P, Feldt-Rasmussen U, Hagen C, Jørgensen 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. — View Citation

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. — View Citation

PLOTZ CM, KNOWLTON AI, RAGAN C. The natural history of Cushing's syndrome. Am J Med. 1952 Nov;13(5):597-614. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No