Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02162706
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease
Endocrine Disorders

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Official Title: Pilot Study of Salivary Cortisol Measurements by Mass Spectrometry
Study Start Date : June 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2025





Primary Outcome Measures :
  1. Salivary Cortisol [ Time Frame: All collections are done within 48 hours ]

Biospecimen Retention:   Samples Without DNA
Saliva was collected using Salivabio children's swab (SCS).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162706


Locations
Layout table for location information
United States, California
Lucile Packard Children's Hospital and Stanford Clinics Recruiting
Stanford, California, United States, 94305
Contact: Tandy Aye, MD    650-723-5791      
Principal Investigator: Tandy Aye, MD         
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Tandy Aye, MD Stanford University