NCT07168122

Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency.

Detailed description

Saliva testing is a non-invasive alternative to blood tests for measuring cortisol, a key hormone for assessing endocrine status and diagnosing conditions like Cushing's syndrome. It accurately reflects physiologically active free cortisol. However, its clinical use is hampered by extremely low cortisol concentrations and the lack of reliable detection methods. We have developed two advanced technologies: an immunomagnetic-bead-based LC-MS assay with simplified preparation, and a fluorescence immunoassay system for point-of-care testing. To promote their clinical adoption, this study will establish normal reference intervals of salivary cortisol for both methods in a healthy population and optimal cut-offs in cases of Cushing's sydrome and adrenal insufficiency.

Conditions

• Healthy Adult
• Cushing Syndrome
• Adrenal Insufficiency

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China