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临床试验/NCT05426135
NCT05426135招募中不适用

Development of an Artificial Intelligence System for Assessment of Tumor Risk and Diagnosis and Treatment Based on Multimodal Data Fusion Using Deep Learning Technology

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
The outcome of clinical diagnosis of suspected patients with colorectal cancer or lesion (Benign/Malignant).

研究概览

简要总结

To improve the accuracy of risk prediction, screening and treatment outcome of cancer, we aim to establish a medical database that includes standardized and structured clinical diagnosis and treatment information, image features, pathological features, and multi-omics information and to develop a multi-modal data fusion-based technology system using artificial intelligence technology based on database.

详细描述

The main aims are as follows:

  1. To establish a data platform for multi-modal information of common tumors (lung cancer/pulmonary nodules, stomach and colorectal cancers) : electronic medical records (including routine clinical detection, treatment, outcome), pathological image data, medical imaging (CT, MRI, ultrasound, nuclear medicine, etc.), multiple omics data (genome, transcriptome, and metabolome, proteomics) omics data, etiology and carcinogenic exposure information.
  2. We will make use of artificial intelligence technology to create the multi-modal medical big data cross-analysis technology and the above disease individualized accurate diagnosis and curative effect prediction models. In order to solve the three key problems of multi-modal data fusion mining, such as unbalanced, small sample size, and poor interpretability, we will establish an artificial intelligence recognition algorithm for image images and pathological images, and use image processing and deep learning technologies to mine multi-level depth visual features of image data and pathological data. In addition, we will use bioinformatics analysis algorithms to conduct molecular network mining and functional analysis of molecular markers at the level of multiple omics technologies (pathologic, genomic, transcriptome, metabolome, proteome, etc.).

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with the suspected of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision
  • Participants that have signed informed consent.
  • Participants with detailed electronic medical records, image records, pathological records, multi-omics information, and other important clinical diagnostic information.
  • Healthy participants with no clinical diagnosis of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision.

排除标准

  • Participants with primary clinical and pathological data missing.
  • Participants lost to follow-up.
  • Participants with too poor medical image quality to perform segment and mark ROI accurately

结局指标

主要结局

The outcome of clinical diagnosis of suspected patients with colorectal cancer or lesion (Benign/Malignant).

时间窗: 2022-2026

① Benign ② Malignant

The outcome of clinical diagnosis of suspected patients with lung cancer/pulmonary nodular (Benign/Malignant nodule)

时间窗: 2022-2026

The outcome of clinical diagnosis of patients with lung cancer/pulmonary nodular (Benign/Malignant nodule). ① Benign nodule ② Malignant neoplasm/nodule: squamous cell carcinoma, adenocarcinoma, small cell carcinoma, and large cell carcinoma.

The outcome of clinical diagnosis of suspected patients with stomach cancer or lesion (Benign/Malignant).

时间窗: 2022-2026

① Benign ② Malignant

Treatment response of anti-cancer therapy at first evaluation in patients with lung/stomach/colorectal cancer (CR, PR, PD, SD).

时间窗: 2022-2026

The treatment response of anti-cancer therapy at first evaluation in patients with lung/stomach/colorectal cancer follows The Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) from the World Health Organization (WHO). The evaluation index is as follows. CR (complete response): Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm. PR (partial response): 30% decrease in the sum of the longest diameter of the target lesions compared with baseline. PD (progressive disease):≥20% increase of at least 5 mm in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded OR The appearance of new lesions, including those detected by FDG-PET (fludeoxyglucose positron emission tomography). SD (stable disease): Neither PR nor PD.

次要结局

未报告次要终点

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Jin

Professor

Wuhan Union Hospital, China

研究点 (1)

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