Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000541202
Ethics application status
Approved
Date submitted
29/06/2009
Date registered
6/07/2009
Date last updated
23/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Utility of Plasma Free Cortisol in the Assessment of Adrenal Function in Patients with Pituitary Disease
Scientific title
The Utility of Plasma Free Cortisol in the Assessment of Adrenal Function in Patients with Pituitary Disease
Secondary ID [1] 287963 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adrenal function 237112 0
Condition category
Condition code
Metabolic and Endocrine 237440 237440 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A 250 mcg synacthen test (250 mcg synacthen administered intramuscularly (IM) with cortisol measurements before and 30 and 60 minutes after synacthen) and a 1 mcg synacthen test (1 mcg synacthen administered intravenously (IV) with cortisol measurements before and 30 and 60 minutes after synacthen). These tests will be performed once each to each subject separated by approximately 7 days. The tests will be performed in healthy subjects (to define a normal reference range) and in subjects with pituitary disease previously defined as either adrenocorticotrophic hormone (ACTH) sufficient or deficient by current gold standard tests.
Intervention code [1] 236833 0
Diagnosis / Prognosis
Comparator / control treatment
The 1mcg and 250 mcg synacthen tests will be performed once each in each subject about 7 days apart. Measurements of total and free cortisol in pituitary subjects by mass spectrometry will be compared to total cortisol by immunoassay. The normal subjects will be used to define the reference range for cortisol by mass spectrometry. The definition of pituitary subjects as either ACTH sufficient or deficient will be historical and based on the assessment of the hypothalamic/pituitary/adrenal (HPA) axis after pituitary surgery.
Control group
Historical

Outcomes
Primary outcome [1] 238239 0
Sensitivity of basal and synacthen-stimulated free cortisol (by mass spectrometry) to diagnose adrenal insufficiency. The normal subjects will be used to define the reference range for cortisol by mass spectrometry. The definition of pituitary subjects as either ACTH sufficient or deficient will be historical and based on the assessment of the HPA axis after pituitary surgery using current gold standard assessments (e.g insulin tolerance test or unequivocally normal or abnormal morning cortisol).
Timepoint [1] 238239 0
At time of study (cross-sectional study)
Secondary outcome [1] 244570 0
Sensitivity of basal and synacthen-stimulated total cortisol (by mass spectrometry) to diagnose adrenal insufficiency. The normal subjects will be used to define the reference range for cortisol by mass spectrometry. The definition of pituitary subjects as either ACTH sufficient or deficient will be historical and based on the assessment of the HPA axis after pituitary surgery using current gold standard assessments (e.g insulin tolerance test or unequivocally normal or abnormal morning cortisol).
Timepoint [1] 244570 0
At time of study (cross-sectional study)

Eligibility
Key inclusion criteria
Pituitary patients: Clearly diagnosed with either ACTH sufficiency/deficiency

Normal volunteers: Age 20-80 yrs
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, advanced malignancy, active infection, liver failure

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
13/03/2009
Date of last participant enrolment
Anticipated
Actual
29/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237223 0
University
Name [1] 237223 0
Flinders University
Country [1] 237223 0
Australia
Primary sponsor type
Government body
Name
Department of Health, South Australia
Address
Citi Centre Building
11 Hindmarsh Square
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 4715 0
None
Name [1] 4715 0
Address [1] 4715 0
Country [1] 4715 0
Other collaborator category [1] 730 0
Hospital
Name [1] 730 0
St Vincent's Hospital
Address [1] 730 0
41 Victoria Parade
Fitzroy Victoria 3065
Country [1] 730 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239321 0
Repatriation General Hospital
Ethics committee address [1] 239321 0
Daws Rd
Daw Park SA 5041
Ethics committee country [1] 239321 0
Australia
Date submitted for ethics approval [1] 239321 0
Approval date [1] 239321 0
14/02/2008
Ethics approval number [1] 239321 0
87/07

Summary
Brief summary
The primary purpose of the study is to determine whether measurement of total and free cortisol by mass spectrometry improves the diagnostic accuracy of synacthen tests to assess adrenal function in patients with pituitary disease.
Trial website
Trial related presentations / publications
Burt MG, Mangelsdorf BL, Rogers A, Ho JT, Lewis JG, Inder WJ, Doogue MP. Free and total plasma cortisol measured by immunoassay and mass spectrometry following ACTH1?24 stimulation in the assessment of pituitary patients. J Clin Endocrinol Metab 2013;98:1883-90
Public notes

Contacts
Principal investigator
Name 29810 0
A/Prof Morton Burt
Address 29810 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd, Daw Park SA041
Country 29810 0
Australia
Phone 29810 0
61882751094
Fax 29810 0
Email 29810 0
[email protected]
Contact person for public queries
Name 13057 0
A/Prof Dr Morton Burt
Address 13057 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 13057 0
Australia
Phone 13057 0
+61 8 82751094
Fax 13057 0
Email 13057 0
[email protected]
Contact person for scientific queries
Name 3985 0
A/Prof Dr Morton Burt
Address 3985 0
Southern Adelaide Diabetes and Endocrine Services
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 3985 0
Australia
Phone 3985 0
+61 8 82751094
Fax 3985 0
Email 3985 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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