Need for a second transurethral resection in high-risk NMIBC patients with negative urine genome-wide low-depth sequencing after initial resection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, multicenter trial enrolling about 428 adults with non-muscle-invasive bladder cancer who are scheduled for a planned second transurethral resection (reTURBT) after an initial TURBT. Between 1 and 6 weeks after the first resection, participants provide a 100 ml urine sample for urinary sediment DNA extraction and genome-wide low-depth sequencing at a central laboratory. Patients with a positive sequencing result will proceed to the second resection, while those with a negative result are randomized 1:2 to either omit the second resection or undergo the planned resection. All participants are followed for two years for recurrence and related outcomes to compare safety and recurrence-free survival between pathways.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with NMIBC who have completed the initial transurethral resection and are scheduled for a second resection, as recommended by guidelines or physician's choice:

  1. Incomplete initial TURBT due to various reasons (including large tumor size, high risk of intraoperative bleeding, extensive tumor range, etc.), posing a risk of residual tumor;
  2. Absence of muscle layer tissue in the initial resection specimen;
  3. Post-initial resection pathology indicating T1 stage;
  4. Post-initial resection pathology indicating G3/high-grade tumor, excluding pure carcinoma in situ;
* Ability to provide a 100ml routine urine sample within 1-6 weeks after the initial resection and before the second resection;
* Age ≥ 18 years;
* Willingness to provide basic clinical information, pathology, and subsequent - recurrence monitoring results;
* Willingness to sign the informed consent form.

Exclusion Criteria:

* Patients with other non-urothelial malignant tumors (including prostate cancer and renal cell carcinoma);
* Patients previously diagnosed with muscle-invasive bladder cancer;
* Patients unable to undergo a second resection;
* Patients with incomplete pathological information of the sample;
* Patients with contaminated samples;
* Patients whose urine samples fail quality control for valid reasons and cannot be resampled;
* Any condition deemed by the investigator as potentially harming the subject or preventing the subject from meeting or fulfilling the study requirements;
* Patients unable to provide written informed consent.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yang xiao, PhD
• Email: yangxiao2915@163.com
• Phone: +8613951813528

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.