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Establishment and evaluation of a visual cortisol detection method based on catalytic hairpin assembly

Establishment and evaluation of a visual cortisol detection method based on catalytic hairpin assembly

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102338
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary tumor

Interventions

Gold Standard:Clinical manifestations of typical Cushing syndrome + positive for any of the following screening tests: A. Two 24-hour urinary free cortisol (UFC) >= the upper limit of normal laborator
B. Overnight 1 mg dexamethasone inhibition test (1 mgDST), serum cortisol > 1.8 µg/dl (> 50 nmol/L)
C. Salivary cortisol > 145 µg/dl (> 4 nmol/L) twice late at night (23:00)
D. Classic low-dose dexamethasone inhibition test (LDDST), serum cortisol > 1.8 µg/dl (> 50 nmol/L
If the clinical manifestations are not typical, a diagnostic test is added: blood cortisol circadian rhythm or low-dose dexamethasone inhibition test + adrenocorticotropin release hormone (CRH) excita
Index test:Visual measurement of cortisol, plasma cortisol, urine cortisol

Sponsors

Yibin Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with Cushing's syndrome: With typical clinical manifestations of Cushing's syndrome + positive for any of the following screening tests: 1. Two 24-hour urinary free cortisol (UFC) >= the upper limit of the laboratory normal value; 2. Overnight 1 mg dexamethasone inhibition test (1 mgDST), serum cortisol > 1.8 µg/dl (> 50 nmol/L); 3. Salivary cortisol > 145 µg/dl (> 4 nmol/L) twice late at night (23:00); 4. Classic low-dose dexamethasone inhibition test (LDDST), serum cortisol > 1.8 µg/dl (> 50 nmol/L; If the clinical manifestations are not typical, a diagnostic test is added: blood cortisol circadian rhythm or low-dose dexamethasone inhibition test + adrenocorticotropin release hormone (CRH) excitation test (Dex-CRH). Healthy people: There was no obvious abnormality of liver and kidney function in our hospital; 2. Accept plasma cortisol testing.

Exclusion criteria

Exclusion criteria: Patients with Cushing's syndrome: 1.. accompanied by other tumors, cardiovascular and cerebrovascular diseases, autoimmune diseases; 2.. other metabolic diseases; 3.. Patients with incomplete case data or incomplete information for other reasons. Healthy people: 1. accompanied by other tumors, cardiovascular and cerebrovascular diseases, autoimmune diseases and other metabolic diseases; 2.. Patients with incomplete case data or incomplete information for other reasons.

Design outcomes

Primary

MeasureTime frame
cortisol;Cut off value;

Secondary

MeasureTime frame
cortisol;Sensitivity;Specificity;Area under the curve;

Countries

China

Contacts

Public ContactLin Qianli

Yibin Second People's Hospital

1549449367@qq.com+86 187 8414 8509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026