Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2017
CompletedStudy Start
First participant enrolled
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 18, 2019
January 1, 2019
2.8 years
March 14, 2017
January 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Salivary free cortisol
Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation test..
1 day
Secondary Outcomes (1)
serum cortisol
1 day
Study Arms (3)
healthy subjects
EXPERIMENTALlow-dose cosyntropin stimulation test
hypoadrenal mitotane treated patients
EXPERIMENTALlow-dose cosyntropin stimulation test
hypoadrenal no-mitotane treated patients
EXPERIMENTALlow-dose cosyntropin stimulation test
Interventions
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.
Eligibility Criteria
You may qualify if:
- mitotane treated
- known hypoadrenlism
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bnai Zion MC
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard Saiegh, MD
Bnai Zion Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 14, 2017
First Posted
March 20, 2017
Study Start
March 14, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
January 18, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share