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

NCT06287541 | Recruiting

• 1 other identifier: 2023-SR-486
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief 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.

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.

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

You may qualify if:

• 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.

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 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.

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, 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

Qiang Lv, Ph.D

CONTACT

doctorlvqiang@sina.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: February 23, 2024
• First Posted: March 1, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: by 2029 for 5 years
• Access Criteria: will be shared under request

Locations

CN (1)