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

NCT07036731 | Recruiting

• 1 other identifier: 2025-SR-310
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Muscle Invasive Bladder Cancer

Keywords

reTURBT; NMIBC; urine biomarker; RFS

Outcome Measures

Primary Outcomes (1)

• 2-year RFS rate

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

  from initial TURBT to the first confirmed recurrence within 2 years

Secondary Outcomes (1)

• RFS

  from initial TURBT to the first confirmed recurrence within 2 years

Study Arms (2)

Urine biomarker -Guided without reTURBT

EXPERIMENTAL

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

Procedure: Urine biomarker -Guided without reTURBT

Standard Care with reTURBT

NO INTERVENTION

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

Interventions

Urine biomarker -Guided without reTURBT PROCEDURE

Participants will proceed without reTURBT

Urine biomarker -Guided without reTURBT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• Absence of muscle layer tissue in the initial resection specimen;
• Post-initial resection pathology indicating T1 stage;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Fanconi Syndrome

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Renal Tubular Transport, Inborn Errors; Kidney Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yang xiao, PhD

CONTACT

+8613951813528; yangxiao2915@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines. Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)