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临床试验/NCT07793110
NCT07793110尚未招募不适用

Construction and Validation of an Early Diagnosis Model for Colorectal Adenoma Based on Laboratory Examinations

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
1
主要终点
Discriminative performance of the clinical prediction model for colorectal adenoma

研究概览

简要总结

Colorectal cancer has the third highest incidence and second highest mortality rate of all malignant tumors worldwide. Distinct from most other cancers, colorectal cancer can be prevented; colonoscopy-based identification and removal of adenomatous polyps is the most effective preventive measure. Early intestinal adenomas rarely cause specific symptoms, and many patients are diagnosed at advanced stages once symptoms emerge, leading to unsatisfactory treatment and prognosis. Colonoscopy, the main diagnostic tool for intestinal adenoma, is invasive, resulting in limited patient compliance, while grassroots hospitals face shortages of medical resources. There is an urgent demand for a convenient, affordable and well-tolerated early diagnostic method for intestinal adenoma. Artificial intelligence techniques can efficiently analyze routine clinical laboratory data. This study aims to establish an AI-based predictive model combining clinical information and laboratory test results to realize early identification of intestinal adenoma and optimize patient prognosis.

详细描述

Colorectal cancer ranks the third in incidence and the second in mortality among all malignant tumors, constituting a major global public health concern. Unlike many other malignancies, colorectal cancer is preventable. Early detection and resection of adenomatous polyps via colonoscopy represent the most effective strategy for colorectal cancer prevention. Intestinal adenomas often present without specific clinical symptoms in the early stage. By the time patients seek medical care due to symptomatic manifestations, most have progressed to the middle or advanced stage, which exerts severe adverse impacts on subsequent therapeutic outcomes and long-term survival prognosis.

Although colonoscopy serves as the primary modality for the early diagnosis of intestinal adenoma, it is an invasive procedure associated with poor adherence among some patients. In addition, primary medical institutions are constrained by limited medical resources. Accurate and timely early diagnosis of intestinal adenoma is closely linked to targeted clinical intervention and improved patient survival outcomes. Therefore, it is critical to identify an early diagnostic approach for intestinal adenoma that boasts high patient acceptance, low technical barriers, convenience and cost-effectiveness. In recent years, with the advancement and wider accessibility of data analytics tools such as artificial intelligence (AI), growing research efforts have focused on addressing this clinical challenge using AI algorithms. Laboratory testing is routinely performed in clinical practice and delivers timely results, and the massive volume of laboratory data provides evidence supporting early disease diagnosis and prognostic prediction. Advances in artificial intelligence enable clinicians to convert abundant clinical data into practical predictive models to enhance diagnostic performance. Accordingly, integrated analysis of electronic medical records and laboratory results using artificial intelligence facilitates timely detection and early diagnosis of intestinal adenoma, and ultimately improves patient survival prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 18 years undergoing colonoscopy, with pathologically confirmed diagnosis of colorectal adenoma or non-adenomatous lesions (e.g., inflammatory polyps, hyperplastic polyps, chronic inflammation, etc.);
  • Capable of reading, understanding and signing the informed consent form;
  • The investigator judges that the subject can understand the procedures of this clinical study, and is willing and able to cooperate with and complete all study procedures.

排除标准

  • Unavailable clinical data including laboratory test results;
  • Neoplastic lesions other than colorectal adenoma;
  • Non-first diagnosis of colorectal adenoma;
  • Autoimmune diseases;
  • Repeated enrolled subjects (duplicate patients);
  • Pregnancy or breastfeeding status;
  • Failure to obtain informed consent;
  • The investigator considers that the subject has high-risk diseases or other special conditions unsuitable for participating in this clinical trial.

研究组 & 干预措施

All enrolled participants

All subjects meeting inclusion criteria will be included in this single cohort. Participants will be divided into a retrospective training subset to construct the predictive model and a prospective validation subset to externally verify model performance for colorectal adenoma prediction.

干预措施: No active intervention (Other)

结局指标

主要结局

Discriminative performance of the clinical prediction model for colorectal adenoma

时间窗: At the time of colonoscopy enrollment

Construct an automatic extraction model for laboratory test data and an early colorectal adenoma diagnosis model based on laboratory test results, and prospectively verify the adenoma detection rate among patients stratified by the model into high-risk and low-risk adenoma groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Honggang

Chief Physician

Renmin Hospital of Wuhan University

研究点 (1)

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