Skip to content

Evaluation of the performance of urine-based DNA methylation assays in urothelial carcinoma: a prospective, multi-center cohort study

Evaluation of the performance of urine-based DNA methylation assays in urothelial carcinoma: a prospective, multi-center cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101440
Enrollment
Unknown
Registered
2025-04-24
Start date
2025-05-06
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Urothelium carcinoma

Interventions

Index test:Urothelial carcinoma gene methylation test kit

Sponsors

Shanghai Changhai Hospital/The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 90 years, with gross or microscopic hematuria. 2. Able to provide enough urine for testing before surgery. 3. Consent to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. With history of any malignancies (including UC). 2. Severe urinary tract infection leading to sepsis. 3. Patients with indwelling catheters, nephrostomy, or cystostomy. 4. Severe liver or kidney failure or other conditions deemed unsuitable for the study. 5. Samples with insufficient DNA content or other quality control failures. 6. Incomplete clinical or pathological data. 7. Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.

Design outcomes

Primary

MeasureTime frame
The sensitivity of the reagent;The specificity of the reagent;

Countries

China

Contacts

Public ContactXu Chuanliang

Shanghai Changhai Hospital/The First Affiliated Hospital of Naval Medical University

chuanliang_xu@126.com+86 138 1632 3268

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026