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Urine DNA-based detection of molecular residual disease in non-muscle invasive bladder cancer (NMIBC): a prospective clinical study

Urine DNA-based detection of molecular residual disease in non-muscle invasive bladder cancer (NMIBC): a prospective clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072635
Enrollment
Unknown
Registered
2023-06-20
Start date
2022-12-17
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

non-muscle invasive bladder cancer

Interventions

Low risk NMIBC patients:N/A
High-Intermediate risk NMIBC patients:N/A

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients who are diagnosed with NMIBC; 2.Age >= 18 years old, male or female; 3.Patients who are proposed to receive clinical treatment including TURBT and/or infusion therapy; 4.It can provide 100mL morning urine samples before initial TURBT, before induced infusion therapy,and before cystoscopy within the follow-up time. For patients undergoing secondary TURBT,100mL morning urine sample needs to be provided before secondary TURBT; 5.Sign informed consent form, willing to comply with the agreement content, good compliance, and participate in follow-up assessment.

Exclusion criteria

Exclusion criteria: 1.NMIBC patients who progressed to MIBC after recurrence; 2.Patients who were diagnosed with other malignancies or received any anti-cancer treatment within 5 years; 3.Patients with other genitourinary tumors (prostate or kidney cancer); 4.Patients who participated in clinical trials of drugs within 3 months before enrollment; 5.The investigator believes that there may be any conditions that increase the risk to the subjects or interfere with clinical trial; 6.Patients whose samples and clinical data are incomplete for all kinds of reasons.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival;

Secondary

MeasureTime frame
Urine DNA-based detection of minimal residual disease;

Countries

China

Contacts

Public ContactYe Dingwei

Fudan University Shanghai Cancer Center

dwyeli@163.com+86 137 0166 3571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026