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临床试验/NCT05096533
NCT05096533Unknown不适用

Prospective Multi-center Clinical Study on the Application Value of Artificial Intelligence in MRI Precision Diagnosis and Treatment of Bladder Cancer

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
To explore the application value of artificial intelligence in the precise diagnosis and treatment of bladder tumor, and to improve the accuracy of MRI diagnosis of bladder cancer stage and grade through artificial intelligence.

研究概览

简要总结

This study was a prospective, multicenter observational clinical study, A total of 150 patients with bladder malignant tumor who was admitted to the urology department of each center for treatment and underwent electric resection or radical cystectomy were planned to be enrolled. In order to analyze the sensitivity、specificity and accuracy of artificial intelligence in predicting postoperative pathological staging, Patients who entered the group were followed up for 3 years, then, we analyzed the correlation between artificial intelligence prediction results and patient OS PFS RFS. It was preliminarily verified that the results of the artificial intelligence model have the potential to predict the prognosis of patients with bladder cancer.

详细描述

Preliminary research: This research is multi-disciplinary joint research by combining artificial intelligence with magnetic resonance, it can make the preoperative determination of bladder cancer stage more accurate and guides the clinician worker's treatment plan. At present, It has been constructed that an artificial intelligence model based on preoperative magnetic resonance images to predict staging and patient prognosis. We built a staging prediction model through deep learning artificial intelligence network, and collected magnetic resonance image data and related postoperative pathological data of patients, afterwards, We followed 576 patients on the basis of staging model construction. By obtaining OS, PFS, and RFS of patients, a part was randomly selected as a training set for training the deep learning network model. The other part is used as a test set to verify its accuracy. This study was a prospective, multicenter observational clinical study, A total of 150 patients with bladder malignant tumor who was admitted to the urology department of each center for treatment and underwent electric resection or radical cystectomy were planned to be enrolled. In order to analyze the sensitivity、specificity and accuracy of artificial intelligence in predicting postoperative pathological staging, Patients who entered the group were followed up for 3 years, then, we analyzed the correlation between artificial intelligence prediction results and patient OS PFS RFS. It was preliminarily verified that the results of the artificial intelligence model have the potential to predict the prognosis of patients with bladder cancer.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Preoperative examination prompts the patient to be bladder cancer;
  • •There is no limit on the gender;
  • •The age of 18 years old or more;
  • •Can provide preoperative MRI images;
  • •Agree to provide personal basic clinical information and pathological and imaging data for scientific research, and sign informed consent;
  • •Agree to provide monitoring results during follow-up monitoring for recurrence.

排除标准

  • •Patient was unable to provide preoperative MRI images, including MRI images after neoadjuvant therapy and before surgery;
  • •Patients with incomplete pathological information of samples were unable to provide accurate staging and grading information;
  • •Patients cannot be operated on due to their own reasons: severe heart failure, acute myocardial infarction, severe heart and lung diseases, etc., they cannot tolerate normal surgical treatment;
  • •Patients who had recently undergone surgery (e.g., TURBT) prior to MRI examination;
  • •The researcher thinks there are any conditions that may impair the subject or cause the subject to fail to meet or perform study requirements;
  • •Patients unable to provide written informed consent.

结局指标

主要结局

To explore the application value of artificial intelligence in the precise diagnosis and treatment of bladder tumor, and to improve the accuracy of MRI diagnosis of bladder cancer stage and grade through artificial intelligence.

时间窗: 1 year

2、Through Concordance analysis of artificial intelligence diagnosis assay results with gold standard results of surgery, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of artificial intelligence diagnosis before the operation.

次要结局

  • Overall survival(3 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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