Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling.
- Who it may be relevant to
- Registry conditions: Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Recurrence, Progression of Bladder Cancer, Transurethral Resection of Bladder Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Predictive Model for Recurrence and Progression Risk After TURBT for Bladder Cancer on Intraoperative Irrigation Fluid Absorption Volume and Perioperative cfDNA Levels
Overview
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.
Detailed description
Bladder cancer is one of the most common malignancies of the urinary system. Non-muscle-invasive bladder cancer accounts for the majority of newly diagnosed cases. Transurethral resection of bladder tumor (TURBT) is the standard procedure for the diagnosis, staging, and initial treatment of bladder cancer, particularly non-muscle-invasive bladder cancer. However, postoperative recurrence and progression remain common in some patients, especially those with high-risk pathological features.
During TURBT, mechanical resection, electrosurgical thermal injury, and continuous bladder irrigation may lead to tumor cell shedding and the release of tumor-derived molecular components into the irrigation fluid. Disruption of the mucosal and vascular barriers, opening of venous sinuses, increased intravesical pressure, and absorption of irrigation fluid may theoretically facilitate the entry of tumor-related components into the circulation. Although previous studies have mainly focused on intravesical tumor cell implantation and local recurrence, the relationship between intraoperative irrigation fluid absorption, perioperative cfDNA dynamics, and postoperative oncological outcomes remains insufficiently understood.
In this prospective observational cohort study, patients undergoing TURBT for suspected or confirmed bladder cancer will be enrolled. Intraoperative irrigation fluid absorption volume will be measured and recorded. Peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis using a multiplex mutation detection system based on nucleic acid mass spectrometry. Tumor tissue mutation status will also be evaluated when available.
The primary objective is to determine whether the volume of intraoperative irrigation fluid absorption is associated with perioperative changes in plasma cfDNA levels and tumor-related mutation detection. Secondary objectives include evaluating the association of cfDNA dynamics and irrigation fluid absorption with clinicopathological characteristics, including tumor stage, grade, size, number, invasion depth, concomitant carcinoma in situ, operative time, resection depth, and blood loss. Postoperative recurrence, progression, metastasis, and other adverse oncological outcomes will be assessed during follow-up.
The study is observational and will not alter standard clinical treatment decisions. The findings may help clarify perioperative molecular changes associated with TURBT and provide preliminary evidence for improving risk stratification and individualized postoperative surveillance in patients with bladder cancer.
Interventions
- Other Measurement 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.
Primary outcome measures
- Change in Plasma cfDNA Level From Before TURBT to Within 24 Hours After TURBT [Time frame: From preoperative blood collection to within 24 hours after TURBT]
Secondary outcome measures (1)
- Detection Rate of Tumor-Related Mutations in Perioperative cfDNA [Time frame: From preoperative blood collection to within 24 hours after TURBT]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Hospital of Lanzhou University — Lanzhou
Identifiers
NCT: NCT07589413 · LZU2H-BCa-Rinse