Clinical trial NCT06632886: AI-Assisted Non-Contrast CT for Multi-Cancer Screening
Official title: A Prospective Cohort Study Evaluating the Utility of Artificial Intelligence-Assisted Non-Contrast Computed Tomography for Multi-Cancer Screening in Asymptomatic Individuals Undergoing Routine Health Examinations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancers
Liver Cancer
Gastric Cancers
Colorectal, Cancer
Esophageal Cancer
Pancreatic Cancer
Breast Cancer
Keywords: Screening
Early Diagnosis
Artificial Intelligence
Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 1000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cancer poses a major public health challenge in China. Early detection can improve treatment outcomes and survival rates. In this study, we will conduct a large-scale, prospective, multi-center cohort study to evaluate the utility of AI-assisted non-contrast CT for multi-cancer screening.

The study aims to enroll 1 million asymptomatic participants undergoing routine health examinations, using an AI imaging model based on non-contrast CT to detect seven cancers such as lung, liver, gastric, colorectal, esophageal, pancreatic, and breast cancers. Positive cases will be required to be referred to Shanghai Changhai Hospital for further imaging and care based on National Comprehensive Cancer Network (NCCN) and American College of Radiology (ACR) guidelines. The goal is to assess the AI model's diagnostic performance for seven cancer types, especially for early-stage, resectable tumors.

Detailed description: Cancer has become a major public health issue in China, seriously affecting population health, the economy, and social development. In 2022, there were an estimated 4.82 million new cancer cases and 2.57 million cancer-related deaths. Lung cancer, liver cancer, gastric cancer, colorectal cancer, esophageal cancer, pancreatic cancer, and breast cancer are the seven leading causes of cancer-related mortality. A successful earlier detection strategy would allow patients to receive timely interventions, improve treatment outcomes, enhance overall survival, and reduce the complexity and cost of treatment.

In this study, we will conduct a large-scale, prospective, multi-center cohort study, aiming to evaluate the utility of AI-assisted non-contrast CT for multi-cancer screening. The population consists of individuals who have undergone non-contrast abdominal or chest CT scans at Meinian Onehealth Health Examination Center or Shanghai Changhai Health Examination Center, with an expected enrollment of 1 million participants. A multi-cancer screening model via non-contrast CT, developed by Alibaba DAMO Academy, will be integrated into the PACS system of health examination centers. The imaging AI model will be used to automatically detect various cancerous lesions, including lung cancer, liver cancer, gastric cancer, colorectal cancer, esophageal cancer, pancreatic cancer, and breast cancer. Subjects identified with positive lesions by the AI model will be required to be referred to Shanghai Changhai Hospital for further imaging examinations (such as contrast-enhanced CT, MRI, Endoscopy, etc.) to confirm the final disease status and formulate a treatment plan. Additionally, the medical team should follow care pathways developed based on guidelines from NCCN and ACR, and if necessary, patients will be directed to the multidisciplinary team (MDT) clinic for specific cancer types to determine the diagnostic procedures. The ultimate goal of this study is to comprehensively assess the diagnostic performance metrics of the AI model for each of the seven cancer types individually. These metrics include, but are not limited to, sensitivity, specificity, and positive/negative predictive value. Particular emphasis will be placed on evaluating the model's efficacy in detecting early-stage, resectable tumors. The overarching aim is to determine whether the implementation of this AI-assisted screening approach could potentially lead to improved overall survival rates through earlier detection and intervention.

Eligibility criteria: Inclusion Criteria:

1. Subject is able and willing to provide informed consent and sign an informed consent form.
2. Subject has undergone an abdominal or chest non-contrast CT scan.

Exclusion Criteria:

1. Subject has been diagnosed with one of the following cancers within the last five years: lung, liver, stomach, colon, esophageal, pancreatic, or breast cancer;
2. Subject has any medical condition that contraindicates high-resolution MRI/CT/Endoscopy;
3. Subject cannot be followed up or is participating in other clinical trials.

Primary outcomes:
measure: Diagnostic yield
timeFrame: 3 years
measure: Incidence
timeFrame: 3 years
measure: Resectable rate
timeFrame: 3 years
Secondary outcomes:
measure: Survival time
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of general surgery, Changhai Hospital
name: Jin Gang, M.D.
role: STUDY_CHAIR
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