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Development and Clinical Validation of a Non-invasive Diagnostic Technique for Urothelial Carcinoma Based on Urinary DNA Methylation

Development and Clinical Validation of a Non-invasive Diagnostic Technique for Urothelial Carcinoma Based on Urinary DNA Methylation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114330
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-12-10
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Urothelial carcinoma

Interventions

Gold Standard:Pathological Diagnosis
Index test:Five urinary methylation biomarkers (BARHL2, HSPA2, SLC8A3, ZNF154, and OTX1)

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients newly diagnosed with urothelial carcinoma and age- and gender-matched patients with benign urological conditions; 2.Complete clinical diagnostic information; 3.Age >= 18 years, no gender restriction

Exclusion criteria

Exclusion criteria: 1.Women who are menstruating; 2.Patients in critical condition, at an advanced stage, or at risk of life-threatening complications; 3.Individuals with mental illness or cognitive impairment; 4.Insufficient urine sample; 5.Specimens for which urine pretreatment was not completed within 48 hours of collection;

Design outcomes

Primary

MeasureTime frame
specificity;Sensitivity;—

Countries

China

Contacts

Public ContactWang Lin

Shanghai General Hospital

wanglin987654321@126.com+86 18817314343

Outcome results

None listed

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