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Salivary Cortisol Measurements by Mass Spectrometry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02162706
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : November 13, 2019
Information provided by (Responsible Party):
Tandy Aye, Stanford University

Tracking Information
First Submitted Date June 11, 2014
First Posted Date June 13, 2014
Last Update Posted Date November 13, 2019
Study Start Date June 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2014)
Salivary Cortisol [ Time Frame: All collections are done within 48 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Salivary Cortisol Measurements by Mass Spectrometry
Official Title Pilot Study of Salivary Cortisol Measurements by Mass Spectrometry
Brief Summary Cortisol is a hormone critical for survival in times of stress. Currently most measurements are done with blood samples. The hypothesis of this study is cortisol measured from saliva using mass spectrometry can be used to replace measurements by blood.
Detailed Description Cortisol levels change depending on the time of day. Salivary samples were collected from health controls at bedtime, midnight and first morning waking on two consecutive nights and salivary cortisol levels were measured using mass spectrometry. In a patients with possible endocrine disorders who were going through an adrenocortiotropin stimulation test for adrenal insufficiency, salivary cortisol was measured prior to giving cosyntropin and 30-40 minutes after cosyntropin.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Saliva was collected using Salivabio children's swab (SCS).
Sampling Method Non-Probability Sample
Study Population Patients with possible endocrine disorders seen during outpatient pediatric endocrinology visit or inpatient consultations. Healthy controls were open to the general public in California.
Condition Endocrine Disorders
Intervention Other: Non intervention study
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2019)
Original Estimated Enrollment
 (submitted: June 12, 2014)
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Normal subjects
  • Subjects with possible endocrine disorder

Exclusion Criteria:

  • Tracheostomy or ventilator dependent
  • Gastrotomy tubed dependent or unable to eat/drink by mouth
Sexes Eligible for Study: All
Ages 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02162706
Other Study ID Numbers Salivary Cortisol
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tandy Aye, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Principal Investigator: Tandy Aye, MD Stanford University
PRS Account Stanford University
Verification Date November 2019