Early Diagnosis Model of Colorectal Adenoma Using Laboratory Examinations
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRenmin Hospital of Wuhan University
About this trial
Colorectal cancer has the third highest incidence and second highest mortality rate of all malignant tumors worldwide. Distinct from most other cancers, colorectal cancer can be prevented; colonoscopy-based identification and removal of adenomatous polyps is the most effective preventive measure. Early intestinal adenomas rarely cause specific symptoms, and many patients are diagnosed at advanced stages once symptoms emerge, leading to unsatisfactory treatment and prognosis. Colonoscopy, the main diagnostic tool for intestinal adenoma, is invasive, resulting in limited patient compliance, while grassroots hospitals face shortages of medical resources. There is an urgent demand for a convenient, affordable and well-tolerated early diagnostic method for intestinal adenoma. Artificial intelligence techniques can efficiently analyze routine clinical laboratory data. This study aims to establish an AI-based predictive model combining clinical information and laboratory test results to realize early identification of intestinal adenoma and optimize patient prognosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged ≥ 18 years undergoing colonoscopy, with pathologically confirmed diagnosis of colorectal adenoma or non-adenomatous lesions (e.g., inflammatory polyps, hyperplastic polyps, chronic inflammation, etc.);
Capable of reading, understanding and signing the informed consent form;
The investigator judges that the subject can understand the procedures of this clinical study, and is willing and able to cooperate with and complete all study procedures.
Disqualifiers
Unavailable clinical data including laboratory test results;
Neoplastic lesions other than colorectal adenoma;
Non-first diagnosis of colorectal adenoma;
Autoimmune diseases;
Trial population
This study enrolls adult patients aged ≥18 years who undergo colonoscopy. Subjects have pathologically confirmed diagnoses of colorectal adenoma or non-adenomatous colorectal lesions. Participants are capable of understanding and signing informed consent and can fully cooperate to complete all study-related procedures. Patients with unavailable laboratory data, other malignant lesions, autoimmune diseases, repeated enrollment records, pregnancy or lactation status will be excluded.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
No active intervention
Other interventionThis is an observational cohort study. No drugs, surgical procedures or therapeutic interventions will be provided to participants. Only routine clinical laboratory and demographic data are collected for constructing and validating a prediction model for colorectal adenoma.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: All enrolled participants1 intervention
Trial outcomes
Primary outcomes
1
Discriminative performance of the clinical prediction model for colorectal adenoma
Construct an automatic extraction model for laboratory test data and an early colorectal adenoma diagnosis model based on laboratory test results, and prospectively verify the adenoma detection rate among patients stratified by the model into high-risk and low-risk adenoma groups.
Time frame
At the time of colonoscopy enrollmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: