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RecruitingNCT07036731Updated Jun 25, 2025

A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing

An interventional study of Urine biomarker -Guided without reTURBT in Non Muscle Invasive Bladder Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
428
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its affiliated centers, who have undergone their initial transurethral resection and are scheduled for a second resection. Within 1-6 weeks after the first resection and prior to the second resection, 100ml of routine urine will be collected and sent within 24 hours to Beijing Genetron Health Clinical Laboratory Co., Ltd. for the extraction of urinary sediment DNA, which will then undergo genome-wide low-depth sequencing. Patients with positive test results will proceed with the second resection, while those with negative results will be randomly assigned in a 1:2 ratio to either the intervention group, which will not undergo a second resection, or the control group, which will undergo the second resection. All enrolled patients will be followed up for two years. The study will statistically analyze and compare the two-year recurrence-free survival rates between the two groups and evaluate the predictive capability of the test results for follow-up recurrence.

02

Conditions studied

  • Non Muscle Invasive Bladder Cancer

Keywords

  • reTURBT; NMIBC; urine biomarker; RFS
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
428 participants (estimated)

Study arms

  • Experimental
    Urine biomarker -Guided without reTURBT

    Participants in this arm will proceed without reTURBT if Urine biomarker tested negative

    Procedure: Urine biomarker -Guided without reTURBT

  • No intervention
    Standard Care with reTURBT

    Participants in this arm will receive standard care, which undergo reTURBT

Interventions

  • ProcedureUrine biomarker -Guided without reTURBT

    Participants will proceed without reTURBT

05

What researchers measure

Primary outcomes

  1. 2-year RFS rate

    the proportion of participants experiencing a recurrence during follow-up within 2 years

    Time frame: from initial TURBT to the first confirmed recurrence within 2 years

Secondary outcomes

  1. RFS

    the duration from the completion of initial TURBT until the first recurrence of cancer is detected or until the end of the follow-up period, whichever comes first.

    Time frame: from initial TURBT to the first confirmed recurrence within 2 years

06

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029
    Nanjing, Jiangsu, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07036731
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Qiang Lv (Principal Investigator, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Jun 25, 2025
Start date
Feb 1, 2025
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Jun 25, 2025

Study contacts

Yang xiao, PhD
Contact
yangxiao2915@163.com
+8613951813528

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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