NCT02162706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

June 11, 2014

Last Update Submit

November 8, 2019

Conditions

Endocrine Disorders

Outcome Measures

Primary Outcomes (1)

  • Salivary Cortisol

    All collections are done within 48 hours

Interventions

Non intervention studyOTHER

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Normal subjects
  • Subjects with possible endocrine disorder

You may not qualify if:

  • Tracheostomy or ventilator dependent
  • Gastrotomy tubed dependent or unable to eat/drink by mouth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital and Stanford Clinics

Stanford, California, 94305, United States

Location

Related Publications (3)

  • Deutschbein T, Unger N, Mann K, Petersenn S. Diagnosis of secondary adrenal insufficiency: unstimulated early morning cortisol in saliva and serum in comparison with the insulin tolerance test. Horm Metab Res. 2009 Nov;41(11):834-9. doi: 10.1055/s-0029-1225630. Epub 2009 Jul 7.

    PMID: 19585406BACKGROUND

  • Baid SK, Sinaii N, Wade M, Rubino D, Nieman LK. Radioimmunoassay and tandem mass spectrometry measurement of bedtime salivary cortisol levels: a comparison of assays to establish hypercortisolism. J Clin Endocrinol Metab. 2007 Aug;92(8):3102-7. doi: 10.1210/jc.2006-2861. Epub 2007 Jun 5.

    PMID: 17550962BACKGROUND

  • Chao CS, Shi RZ, Kumar RB, Aye T. Salivary cortisol levels by tandem mass spectrometry during high dose ACTH stimulation test for adrenal insufficiency in children. Endocrine. 2020 Jan;67(1):190-197. doi: 10.1007/s12020-019-02084-8. Epub 2019 Sep 18.

    PMID: 31535345RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva was collected using Salivabio children's swab (SCS).

MeSH Terms

Conditions

Endocrine System Diseases

Study Officials

  • Tandy Aye, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 13, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

US(1)