The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

Non Muscle Invasive Bladder Cancer Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Study Comparing the Necessity of a Second Transurethral Resection of Bladder Tumor in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287541
• Other study ID #: 2023-SR-486
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2027

Study information

• Verified date: February 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Qiang Lv, Ph.D
• Email: doctorlvqiang[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT.

Description:

This clinical trial aims to address the clinical question of whether a urine biomarker test can effectively guide the decision-making process regarding the necessity of reTURBT (repeat transurethral resection of bladder tumor) in patients with non-muscle-invasive bladder cancer (NMIBC). The primary objective is to assess whether patients with negative urine biomarker tests can safely avoid reTURBT. Participants eligible for enrollment in this study will be randomized in a 1:2 ratio into two 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. Following reTURBT, they will also receive standard follow-up care. The main task for participants will involve providing urine samples for the biomarker test before reTURBT. Those in Group B will additionally undergo reTURBT, a standard surgical procedure involving the removal of residual tumor tissue from the bladder.Throughout the study period, researchers will assess their recurrence-free survival rates and RFS. The goal is to determine whether the urine biomarker test can safely spare patients from unnecessary reTURBT while maintaining comparable RFS rates. This study adheres to ethical guidelines and has obtained approval from the appropriate institutional review boards. Participant confidentiality and data integrity will be strictly maintained throughout the study duration. The results of this trial have the potential to inform clinical practice guidelines and improve the management of NMIBC patients by offering a personalized approach to treatment decision-making.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: July 1, 2027
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with NMIBC who have undergone initial TURBT and are scheduled for reTURBT surgery as recommended by guidelines or chosen by their physicians;
• Patients who have tested negative for urine biomarkers after the initial TURBT and before the second TURBT;
• Age = 18 years;
• Willingness to provide personal basic clinical information, as well as pathology and subsequent recurrence monitoring results;
• Willingness to sign informed consent.

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 transurethral resection;
• Patients with incomplete sample pathology information;
• Any condition perceived by the researcher to potentially harm the subjects or prevent them from meeting or executing the study requirements;
• Patients unable to provide written informed consent.

Related Conditions & MeSH terms

• Non Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Urine biomarker -Guided without reTURBT
Participants will proceed without reTURBT

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	from initial TURBT to the first confirmed recurrence within 2 years