A prospective, multicenter clinical study of urine DNA methylation/mutation testing in the diagnosis of urothelial carcinoma of the bladder

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100053432

Enrollment

Unknown

Registered

2021-11-21

Start date

2021-11-19

Completion date

Unknown

Last updated

2022-09-26

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

Conditions

Bladder cancer

Interventions

Gold Standard:Pathological diagnosis

Index test:Urine&#32

DNA&#32

methylation/mutation&#32

detection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Case group: 1. >=18 years old, gender is not limited; 2. Be able to provide 100mL morning urine and 100mL random urine samples before treatment while receiving conventional treatment; 3. Diagnosed with urothelial carcinoma of the bladder, ureter, and renal pelvis after surgery (combined with benign diseases/cysts of the urinary system). Interference group: 1. >=18 years old, gender is not limited; 2. Be able to provide 100mL morning urine and 100mL random urine samples before treatment while receiving conventional treatment; 3. Other urological malignancies other than urothelial carcinoma diagnosed by surgery, such as bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/kidney cancer. Control group: 1. >=18 years old, gender is not limited; 2. Provide 100mL morning urine and 100mL random urine samples before treatment; 3. Clinically diagnosed as benign urinary diseases, including urinary calculi, urinary tract infections (except urinary tract tuberculosis), benign prostatic hyperplasia, and glandular cystitis. Healthy group: 1. >=18 years old, gender is not limited; 2. Able to provide 100mL morning urine sample within 1 month after physical examination; 3. People with normal urinalysis/ultrasonic examination results and no suspected tumors of other organs.

Exclusion criteria

Exclusion criteria: Case group/interference group/control group: 1. In addition to bladder cancer, there is a history of other malignant tumors in the past; 2. Any other reasons considered by the principal investigator of each clinical unit shall be recorded in detail. Healthy group: Any other reasons considered by the principal investigator of each clinical unit should be recorded in detail.

Design outcomes

Primary

Measure	Time frame
Urine DNA methylation;	—

Secondary

Measure	Time frame
Urine DNA mutation detection;	—

Countries

China

Contacts

Public ContactHuang Jian

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

hjgcp2017@163.com+86 13600054833

Outcome results

None listed

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