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Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT

9 mai 2026 mis à jour par: Zhiping Wang

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

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

150

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Gansu
      • Lanzhou, Gansu, Chine, 730030
        • Recrutement
        • The Second Hospital of Lanzhou University
        • Contact:
          • Hongqin Zhao, Master of Medicine
          • Numéro de téléphone: +86 13830170665
          • E-mail: 1372389220@qq.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Non-urothelial bladder malignancy confirmed by pathology.
  2. History of other malignant tumors within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
  3. Previous radical cystectomy or systemic antitumor therapy before enrollment.
  4. Inadequate blood sample quality or insufficient DNA yield for mutation analysis.
  5. Pregnancy or breastfeeding.
  6. 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Plasma cfDNA Level From Before TURBT to Within 24 Hours After TURBT
Délai: From preoperative blood collection 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Detection Rate of Tumor-Related Mutations in Perioperative cfDNA
Délai: From preoperative blood collection to within 24 hours after TURBT
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.
From preoperative blood collection to within 24 hours after TURBT

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Zhiping Wang, Lanzhou University Second Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

1 mai 2026

Première soumission répondant aux critères de contrôle qualité

9 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

The possibility of sharing de-identified individual participant data will be evaluated after study completion. Any future data sharing will depend on the scope of informed consent, institutional policies, ethics approval requirements, and the establishment of appropriate data use agreements. Shared data, if available, will not contain personally identifiable information.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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