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Development, validation, and clinical application of a novel tumor marker based on urine DNA methylation for the non-invasive diagnosis of urinary for urothelial carcinoma

Development, validation, and clinical application of a novel tumor marker based on urine DNA methylation for the non-invasive diagnosis of urinary for urothelial carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064162
Enrollment
Unknown
Registered
2022-09-28
Start date
2022-09-22
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Urothelial carcinoma

Interventions

patients were classified as non-neoplastic diseases if none of the promoter regions are methylated.
Index test:Urine DNA methylation: Patients are classified as urothelial carcinoma if at least one promoter region of 15 specified sites are methylated

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The experimental group: Patients who were initially diagnosed with urothelial carcinoma by clinical imaging (CT or MRI), and planned to undergo surgical treatment, and were finally confirmed as urothelial carcinoma by postoperative pathology. The control group: Non-neoplastic diseases of the urinary system were excluded clinically (imaging and blood tumor markers ).

Exclusion criteria

Exclusion criteria: The experimental group: 1. Patients had contraindications for surgery; 2. Patients had a history of bladder cancer, prostatecancer, or other malignant tumors of the urinary system; 3. Patients planned to undergo radical bladder resection in the short term and could not complete the follow-up study; 4. Patients refused to sign the informed consent and participate in this clinicalstudy. The control group: 1. Patients had a history of bladder cancer, prostate cancer, or other malignant tumors of the urinary system; 2. Patients refused to sign the informed consent and participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Sensitivity;

Secondary

MeasureTime frame
Specificity;Positive predictive value;Negative predictive value;Overall consistency;

Countries

China

Contacts

Public ContactZhou Liqun

Peking University First Hospital

zhoulqmail@sina.com+86 10 83572418

Outcome results

None listed

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