Multimodal Artificial Intelligence for Non-Invasive Colorectal Cancer Screening Based on Holographic Biology

September 6, 2026 updated by: Xiuli Zuo

Multimodal Artificial Intelligence for Non-Invasive Colorectal Cancer Screening Based on Holographic Biology.

The purpose of this study is to propose a non-invasive screening method by integrating holographic biological theory and artificial intelligence technology. A colorectal cancer risk assessment model will be constructed by analyzing multimodal data including facial features, tongue image characteristics and exhaled gas. The hypothesis of this study is that the model can attain both sensitivity and specificity of 80%.This study will enroll patients aged 18-80 years scheduled to undergo colonoscopy. All participants shall provide informed consent and sign the informed consent form. Patients will be excluded if they have severe cardiac, cerebral, pulmonary or renal dysfunction, or psychiatric disorders precluding colonoscopy, have a history of gastrointestinal surgery, or have taken bismuth agents or other staining medications. Based on estimates from existing literature, the training set will require tongue images, facial images, exhaled gas analysis results and colonoscopic diagnoses from 5000 patients, and the test set will require such data from 6000 patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

11000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants aged 18-80 years who are scheduled to undergo colonoscopy. All participants provide informed consent. This study enrolls subjects preparing for colonoscopic examination to collect multimodal data for constructing an artificial intelligence-based colorectal cancer risk assessment model.

Description

Inclusion Criteria:

  1. Patients aged 18-80 years scheduled to undergo colonoscopy.
  2. All patients provide informed consent and sign the informed consent form.

Exclusion Criteria:

  1. Patients with severe cardiac, cerebral, pulmonary or renal dysfunction, or psychiatric disorders that prevent colonoscopy;
  2. Patients with a history of gastrointestinal surgery;
  3. Patients taking bismuth agents or other staining medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of colonic polyps and colorectal cancer.
Time Frame: At the time of enrollment and colonoscopy examination
At the time of enrollment and colonoscopy examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiuli Zuo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 6, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-2026-06-037-1

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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