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.
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.
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.
This study will include adults aged 18 years or older with suspected or confirmed bladder urothelial carcinoma who are scheduled to undergo TURBT at the Second Hospital of Lanzhou University. Eligible participants must be able to provide sufficient peripheral blood samples for cfDNA extraction and mutation analysis. Postoperative pathological diagnosis will be used to confirm eligibility for the final analysis when applicable. Patients will receive standard clinical management, and participation in this observational study will not affect treatment decisions.
Cohort
Prospective
Measurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling
Other interventionThis 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.
Change in Plasma cfDNA Level From Before TURBT to Within 24 Hours After TURBT
The primary outcome is the perioperative change in plasma cfDNA level, calculated by comparing cfDNA concentration before TURBT and within 24 hours after TURBT. The association between intraoperative irrigation fluid absorption volume and cfDNA change will be evaluated.
Detection Rate of Tumor-Related Mutations in Perioperative cfDNA
The detection rate of bladder cancer-related mutations in plasma cfDNA before and after TURBT will be assessed using a multiplex mutation detection system based on nucleic acid mass spectrometry.
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Zhiping Wang
Lead sponsor
Lanzhou University Second Hospital
Sponsor institution
