Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06632886

A Prospective Cohort Study Evaluating AI-Assisted Non-Contrast CT for Multi-Cancer Screening in Asymptomatic Adults Undergoing Routine Health Exams

Led by Guo ShiWei · Updated on 2024-10-09

1000000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cancer is a major public health concern in China, with millions of new cases and deaths each year. This research aims to evaluate the use of an artificial intelligence (AI) model applied to non-contrast CT scans to screen for seven common cancers: lung, liver, gastric, colorectal, esophageal, pancreatic, and breast cancers. The study focuses on asymptomatic individuals undergoing routine health exams to detect early-stage, treatable tumors and improve survival. Participants receive abdominal or chest non-contrast CT scans as part of routine health checks at specific health examination centers. The AI model, developed by Alibaba DAMO Academy, is integrated into the imaging system to automatically detect possible cancerous lesions. Those flagged by the AI will be referred to Shanghai Changhai Hospital for further diagnostic imaging such as contrast-enhanced CT, MRI, or endoscopy, and guided by established cancer care guidelines to plan treatment. During the study, researchers will track participants through assessments and follow-ups for up to three years to measure diagnostic accuracy, cancer incidence, and the rate of tumors that can be surgically removed. They will also monitor survival time. The study involves a large cohort of up to one million people and aims to comprehensively assess how well the AI screening can detect different cancers early and improve overall outcomes.

CONDITIONS

Brief Title

AI-Assisted Non-Contrast CT for Multi-Cancer Screening

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide informed consent
  • Has undergone an abdominal or chest non-contrast CT scan
Not Eligible

You will not qualify if you...

  • Diagnosed with lung, liver, stomach, colon, esophageal, pancreatic, or breast cancer within the last 5 years
  • Has a medical condition that contraindicates high-resolution MRI, CT, or endoscopy
  • Cannot be followed up or is currently participating in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Ongoing during routine health examinations

Participants undergo AI-assisted non-contrast CT scans during routine health examinations to detect potential cancerous lesions. Those identified with positive lesions will have additional diagnostic tests including blood tests and further imaging to confirm diagnosis and plan treatment.

1 visit during routine health examination; additional visits as needed for confirmatory tests

Long-term Monitoring

Duration - Up to 3 years

Participants are followed for up to 3 years to assess diagnostic outcomes such as cancer incidence, resectable tumor rates, and survival time.

Follow-up visits as part of routine care and monitoring

Trial Site Locations

Total: 1 location

1

Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

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Research Team

W

Wang Beilei, M.D.

G

Guo Shiwei, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies.

Q Gao, Y P Lin, B S Li...

https://pubmed.ncbi.nlm.nih.gov/36849097