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Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients
Plain-language guide to NCT03083834: not phased non-randomized trial of Cosyntropin, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03083834
- Phase
- not phased
- Status
- status unknown
- Start
- 2017-03-14
- Completion (planned or actual)
- 2019-12-31
- Participants
- 50 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Adrenal Insufficiency; Adrenal Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Cosyntropin.
Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the free serum cortisol.
It had three arms (groups): healthy subjects (experimental), one (experimental) and one (experimental).
The registry classes the interventions as diagnostic test.
More on the Plan
Salivary free cortisol (SC) is an index of plasma free cortisol.
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.
Who Took Part
The registry lists 50 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 2 inclusion and 1 exclusion criteria.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Cosyntropin group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Cosyntropin study: the participants and staff both knew the treatment.
It started in 2017-03-14 with completion listed for 2019-12-31.
It ran at 1 site in Israel.
Its stated primary purpose is diagnostic.
What Was Measured
Researchers chose this as the main measure: Salivary free cortisol (time frame: 1 day).
It also tracked 1 secondary outcome, for example serum cortisol.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Cosyntropin in 50 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cosyntropin compound page, all human trials.
Our Notes on the Compound
Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.