이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT

2026년 5월 9일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

150

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Gansu
      • Lanzhou, Gansu, 중국, 730030
        • 모병
        • The Second Hospital of Lanzhou University
        • 연락하다:
          • Hongqin Zhao, Master of Medicine
          • 전화번호: +86 13830170665
          • 이메일: 1372389220@qq.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Plasma cfDNA Level From Before TURBT to Within 24 Hours After TURBT
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Detection Rate of Tumor-Related Mutations in Perioperative cfDNA
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Zhiping Wang, Lanzhou University Second Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 1일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2027년 4월 1일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 9일

처음 게시됨 (실제)

2026년 5월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 9일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

방광의 요로상피암종에 대한 임상 시험

구독하다