- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426135
Artificial Intelligence System for Assessment of Tumor Risk and Diagnosis and Treatment
Development of an Artificial Intelligence System for Assessment of Tumor Risk and Diagnosis and Treatment Based on Multimodal Data Fusion Using Deep Learning Technology
Study Overview
Status
Detailed Description
The main aims are as follows:
- 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.
- 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.).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yang Jin
- Phone Number: 15107177084
- Email: whuhjy@126.com
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430000
- Recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Lung cancer group
Participants with lung cancer/pulmonary nodules
|
Stomach cancer group
Participants with Stomach cancer/Stomach lesion
|
Colorectal cancer group
Participants with Colorectal cancer/Colorectal lesion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The outcome of clinical diagnosis of suspected patients with lung cancer/pulmonary nodular (Benign/Malignant nodule)
Time Frame: 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. |
2022-2026
|
The outcome of clinical diagnosis of suspected patients with stomach cancer or lesion (Benign/Malignant).
Time Frame: 2022-2026
|
① Benign ② Malignant |
2022-2026
|
The outcome of clinical diagnosis of suspected patients with colorectal cancer or lesion (Benign/Malignant).
Time Frame: 2022-2026
|
① Benign ② Malignant |
2022-2026
|
Treatment response of anti-cancer therapy at first evaluation in patients with lung/stomach/colorectal cancer (CR, PR, PD, SD).
Time Frame: 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. |
2022-2026
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jin_cancer risk
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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