Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT

NCT07589413 | Recruiting

• 1 other identifier: LZU2H-BCa-Rinse
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

bladder cancer; nucleic acid mass spectrometry; TURBT; urothelial carcinoma; cell-free DNA; irrigation fluid absorption; circulating tumor DNA; mutation profiling; recurrence; progression

Outcome Measures

Primary Outcomes (1)

• 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.

  From preoperative blood collection to within 24 hours after TURBT

Secondary Outcomes (1)

• Detection Rate of Tumor-Related Mutations in Perioperative cfDNA

  From preoperative blood collection to within 24 hours after TURBT

Study Arms (1)

Patients Undergoing TURBT for Bladder Cancer

Adult patients with suspected or confirmed bladder urothelial carcinoma who are scheduled to undergo TURBT will be enrolled. Intraoperative irrigation fluid absorption volume, perioperative plasma cfDNA levels, mutation status, clinicopathological features, and postoperative oncological outcomes will be collected and analyzed.

Other: Measurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling

Interventions

Measurement of Intraoperative Irrigation Fluid Absorption and Perioperative cfDNA Profiling OTHER

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.

Patients Undergoing TURBT for Bladder Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhiping Wang: lead

Study Sites (1)

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected before TURBT and within 24 hours after TURBT for plasma cfDNA extraction and mutation analysis. Tumor tissue samples obtained during TURBT will be used for pathological diagnosis and mutation analysis when available. Biospecimens will be stored and processed according to institutional protocols and ethics approval requirements.

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Recurrence; Disease Progression

Condition Hierarchy (Ancestors)

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhiping Wang

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)