AI-Driven Cancer Diagnosis and Prediction With EHR

NCT ID: NCT06791473

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-19

Study Completion Date

2025-10-01

Brief Summary

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This is a multi-center, clinical study designed to evaluate the application and effectiveness of an AI-assisted predictive model for identifying and diagnosing cancer, leveraging multimodal health data.

Detailed Description

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Cancer diagnosis and early detection are crucial for improving patient outcomes and survival rates. Early identification of cancers and appropriate intervention can significantly impact treatment success and prognosis. In clinical practice, oncologists often need to integrate a variety of patient data-including medical history, laboratory test results, imaging data such as CT scans and MRIs, and genetic markers-to make an accurate diagnosis and develop a personalized treatment plan.

To build the foundation for our work, first phase of the project was initiated in 2023, conducting a large-scale retrospective study. This foundational phase involved analyzing comprehensive, multimodal data from approximately 1 million cancer patients. The goal was to identify key patterns and build robust preliminary models.

As precision medicine becomes increasingly important, the challenge remains to identify cancer at early stages, especially when symptoms are subtle or absent. Building on the insights from our initial analysis, the project's second phase was launched in February 2025: a prospective study. This current study aims to develop and validate an AI-assisted decision-making system by integrating multimodal data from electronic health records, imaging, laboratory results, and genetic data in a real-world clinical setting. The objective is to improve diagnostic accuracy, optimize clinical workflows, and provide more personalized treatment options for cancer patients. Ultimately, through this comprehensive, two-phase approach, this system seeks to improve early detection, guide effective treatment strategies, and enhance patient survival rates.

Conditions

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Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Healthy Cohort

This group consists of individuals without any diagnosed cancer. Participants in this cohort will serve as the control group for comparison to the experimental group. No interventions or treatments will be administered to this cohort, as they represent a baseline of healthy individuals.

AI-Based Diagnostic and Prognostic Model

Intervention Type DIAGNOSTIC_TEST

This intervention involves an AI system that integrates multimodal data, including patient medical history, laboratory test results, imaging data, and genetic information, to predict the risk of cancer. The system uses deep learning algorithms to provide real-time, accurate predictions, enabling early identification of cancer risks. By analyzing historical health data, the model aims to predict potential cancer developments, improving early detection and treatment outcomes.

Tumor Cohort

This group consists of individuals diagnosed with cancer, including various types. Participants in this cohort will serve as the experimental group for evaluating the effectiveness of the early prediction model in identifying cancer risks and improving diagnostic accuracy.

AI-Based Diagnostic and Prognostic Model

Intervention Type DIAGNOSTIC_TEST

This intervention involves an AI system that integrates multimodal data, including patient medical history, laboratory test results, imaging data, and genetic information, to predict the risk of cancer. The system uses deep learning algorithms to provide real-time, accurate predictions, enabling early identification of cancer risks. By analyzing historical health data, the model aims to predict potential cancer developments, improving early detection and treatment outcomes.

Interventions

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AI-Based Diagnostic and Prognostic Model

This intervention involves an AI system that integrates multimodal data, including patient medical history, laboratory test results, imaging data, and genetic information, to predict the risk of cancer. The system uses deep learning algorithms to provide real-time, accurate predictions, enabling early identification of cancer risks. By analyzing historical health data, the model aims to predict potential cancer developments, improving early detection and treatment outcomes.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1、Patients with comprehensive electronic health records (EHRs), including medical history, laboratory test results, imaging data, and genetic data (if available).

2\. Individuals without severe cognitive impairments or conditions that would prevent them from providing informed consent or participating in the study.

3\. Parents or guardians must provide informed consent for minors, while adult participants must provide informed consent for themselves.

Exclusion Criteria

1. Patients with incomplete or missing key electronic health record data or insufficient follow-up data.
2. Individuals with severe cognitive disorders or other terminal illnesses that would prevent meaningful participation.
3. Pregnant women (although pediatric cancers are being considered, pregnant women would be excluded for safety reasons).
Minimum Eligible Age

0 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Eye Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kang Zhang

Chief Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Liu, MD

Role: CONTACT

+86 13810512704

Facility Contacts

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Bingzhou Li, MD

Role: primary

+86-0756-2222569

Zhuomin Li, MD

Role: primary

+86-0577-85397527

Yunfang Yu, MD

Role: primary

+86 020-81332199

Yuxing Lu, MD

Role: primary

+86 13161233730

Kai Wang, MD

Role: primary

+86 028-85422114

Cheng Tang, MD

Role: primary

Sian Liu, MD

Role: primary

+86-0577-88002888

Other Identifiers

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Cancer

Identifier Type: -

Identifier Source: org_study_id

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