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Methodological Comparison Study for Steroid Hormone Detection (Liquid Chromatography-Tandem Mass Spectrometry)

Methodological Comparison Study for Steroid Hormone Detection (Liquid Chromatography-Tandem Mass Spectrometry)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110544
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Diseases related to steroid hormone deficiency, such as:AME,CAH,5a-reductase deficiency

Interventions

Gold Standard:Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Index test:Ionify Steroids 2 (iST2) kit (liquid chromatography-tandem mass spectrometry) (LC-MS/MS)

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. There is no restriction on the age or gender of the subjects. 2. The indications are for the following populations: 2.1 Populations such as those with apparent mineralocorticoid excess, hypertension, hypokalemia, alkalosis, etc., who need cortisol testing. 2.2 Populations such as those with congenital adrenal hyperplasia (including 21-hydroxylase deficiency, 11ß-hydroxylase deficiency, 3ß-hydroxysteroid dehydrogenase deficiency, etc.), polycystic ovary syndrome, infertility, menstrual disorders, etc., who need dehydroepiandrosterone testing. 2.3 Populations such as those with 5a-reductase deficiency, polycystic ovary syndrome, adrenal tumors, adrenal nodules, disorders of sex development, etc., who need dihydrotestosterone testing. 3. The subjects are voluntary and can accept having about 5 mL of blood drawn once.

Exclusion criteria

Exclusion criteria: 1. Samples from the same subject enrolled repeatedly; 2. Samples thawed more than once; 3. Samples not suitable for testing, such as samples with visible blood clots or contamination upon visual inspection.

Design outcomes

Primary

MeasureTime frame
cortisol;Dihydrotestosterone, DHT;Dehydroepiandrosterone, DHEA;consistency;

Countries

China

Contacts

Public ContactLi Jiang

Sichuan Provincial People's Hospital

u0341992@yahoo.com+86 28 87394037

Outcome results

None listed

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