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Application of urine DNA methylation in noninvasive diagnosis of residual and recurrent bladder cancer

Application of urine DNA methylation in noninvasive diagnosis of residual and recurrent bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058404
Enrollment
Unknown
Registered
2022-04-08
Start date
2022-03-25
Completion date
Unknown
Last updated
2024-01-08

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:Urine routine examination, imaging, pathological results of urine exfoliated cells and urine FISH results
Index test:Urine DNA methylation

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Judge the case group of tumor residue: (1) Patients with previously diagnosed high-risk NMIBC are proposed to undergo secondary TURBT; (2) Age >= 18 years old, regardless of gender; (3) The interval between the last infusion of chemotherapeutic drugs or immunotherapeutic drugs is 1 week or more; (4) It can provide 100ml morning urine sample before treatment while receiving routine treatment; (5) Tumor residue was confirmed by TURBT operation and pathology. 2. Control group for judging tumor residue: (1) Patients with previously diagnosed high-risk NMIBC are proposed to undergo secondary TURBT; (2) Age >= 18 years old, regardless of gender; (3) The interval between the last infusion of chemotherapeutic drugs or immunotherapeutic drugs is 1 week or more; (4) It can provide 100ml morning urine sample before treatment while receiving routine treatment; (5) No residual tumor was diagnosed by TURBT. 3. Case group for judging tumor recurrence (1) Patients with previously diagnosed NMIBC after TURBT are planned to undergo follow-up cystoscopy; (2) Age >= 18 years old, regardless of gender; (3) The interval between the last infusion of chemotherapeutic drugs or immunotherapeutic drugs is 1 week or more; (4) It can provide 100ml morning urine sample before treatment while receiving routine treatment; (5) The tumor recurrence was confirmed by cystoscopy and biopsy pathology. 4. Judgment of tumor recurrence in control group: (1) Patients with previously diagnosed NMIBC after TURBT are planned to undergo follow-up cystoscopy; (2) Age >= 18 years old, regardless of gender; (3) The interval between the last infusion of chemotherapeutic drugs or immunotherapeutic drugs is 1 week or more; (4) It can provide 100ml morning urine sample before treatment while receiving routine treatment; (5) No tumor recurrence was confirmed by cystoscopy and biopsy.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

MeasureTime frame
Urine DNA methylation;

Countries

China

Contacts

Public ContactChen Xu

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

sys_urology_gcp@163.com+86 020-34071357

Outcome results

None listed

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