- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03083834
Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients
In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases cortisol binding globulin levels (CBG), artificially raising total cortisol. Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the free serum cortisol.
In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
80-90% of circulating cortisol is bound to cortisol binding globulin (CBG) or transcortin, whereas only 3-10% is in the free state. Salivary free cortisol (SC) is an index of plasma free cortisol. In previous studies it was shown that in low-dose cosyntropin stimulation test, SC increases significantly in normal but not in hypoadrenal patients. It was suggested that dynamic assessment of the SC response to ACTH may be particularly helpful whenever the measurement of serum cortisol is complicated by increased or decreased CBG levels.
Adrenocortical carcinoma (ACC) is a rare malignancy with a heterogeneous presentation and a variable but generally poor prognosis. Mitotane is the main drug for ACC treatment and it plays a role both in adjuvant treatment after complete resection and in recurrent, inoperable and/or metastatic ACC. Mitotane blocks adrenocortical steroid synthesis and also exerts a specific cytotoxic effect on adrenocortical cells. Mitotane induces adrenal insufficiency, requiring hydrocortisone replacement therapy. In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases CBG levels, artificially raising total cortisol. SC is not affected by CBG alterations, and reflects the free serum cortisol and may be more accurate in diagnosing hypoadrenalism in mitotane treated patients.
In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from any other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leonard Saiegh, MD
- Phone Number: +972506267262
- Email: leonard.saiegh@gmail.com
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Bnai Zion Mc
-
Contact:
- Leonard Saiegh
- Phone Number: 506267262
- Email: leonard.saiegh@gmail.com
-
Contact:
- Michal Yeiches
- Phone Number: 0528283062
- Email: yeiches@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- mitotane treated
- known hypoadrenlism
Exclusion Criteria:
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: healthy subjects
low-dose cosyntropin stimulation test
|
At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein.
Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%).
Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.
|
Experimental: hypoadrenal mitotane treated patients
low-dose cosyntropin stimulation test
|
At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein.
Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%).
Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.
|
Experimental: hypoadrenal no-mitotane treated patients
low-dose cosyntropin stimulation test
|
At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein.
Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%).
Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary free cortisol
Time Frame: 1 day
|
Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation test..
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum cortisol
Time Frame: 1 day
|
Serum cortisol concentrations during intravenous low dose cosyntropin stimulation test.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leonard Saiegh, MD, Bnai Zion Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0006-17-BNZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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