RecruitingNCT07589413

Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT

A Predictive Model for Recurrence and Progression Risk After TURBT for Bladder Cancer on Intraoperative Irrigation Fluid Absorption Volume and Perioperative cfDNA Levels

Sponsor

Zhiping Wang

Enrollment

150 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Bladder Cancer Recurrence Progression of Bladder Cancer Transurethral Resection of Bladder Tumor Urothelial Carcinoma of the Bladder

Summary

This prospective observational cohort study aims to evaluate the association between intraoperative irrigation fluid absorption and perioperative cell-free DNA (cfDNA) dynamics in patients undergoing transurethral resection of bladder tumor (TURBT). Eligible patients with suspected or confirmed bladder cancer scheduled for TURBT will be enrolled. Intraoperative irrigation fluid absorption volume will be recorded, and peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis. The study will assess whether irrigation fluid absorption volume is associated with changes in cfDNA concentration, tumor-related mutation detection, and clinicopathological features, including tumor stage, grade, size, number, invasion depth, concomitant carcinoma in situ, operative time, resection depth, and intraoperative blood loss. Patients will also be followed for postoperative recurrence, progression, metastasis, and other adverse oncological outcomes. This study may provide preliminary evidence for understanding perioperative tumor-related molecular changes during TURBT and may help improve risk stratification, perioperative management, and postoperative follow-up strategies for patients with bladder cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age 18 years or older.
Suspected or histologically confirmed urothelial carcinoma of the bladder.
Scheduled to undergo TURBT.
Availability of sufficient peripheral blood samples for cfDNA extraction and mutation analysis.
Availability of complete clinicopathological and perioperative data.
Ability to provide informed consent and comply with study follow-up.

Exclusion Criteria6

Non-urothelial bladder malignancy confirmed by pathology.
History of other malignant tumors within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
Previous radical cystectomy or systemic antitumor therapy before enrollment.
Inadequate blood sample quality or insufficient DNA yield for mutation analysis.
Pregnancy or breastfeeding.
Serious uncontrolled intercurrent illness that may interfere with study participation, follow-up, or compliance, including active infection, symptomatic congestive heart failure, unstable angina, clinically significant arrhythmia, severe psychiatric illness, or other conditions judged by the investigator to make participation unsuitable.

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Interventions

OTHERMeasurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling

This is an observational exposure assessment. Intraoperative irrigation fluid absorption volume will be recorded during TURBT using a dedicated measurement system. Peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis. Tumor tissue mutation status will be assessed when available. No active therapeutic intervention, treatment modification, or change in clinical decision-making will be performed as part of this study.