ClinicalTrials.gg
Not yet recruitingNCT07793110Updated Aug 28, 2026

Early Diagnosis Model of Colorectal Adenoma Using Laboratory Examinations

An observational study in Colorectal Adenoma and Polyp, sponsored by Renmin Hospital of Wuhan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Renmin Hospital of Wuhan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Colorectal cancer ranks the third in incidence and the second in mortality among all malignant tumors, constituting a major global public health concern. Unlike many other malignancies, colorectal cancer is preventable. Early detection and resection of adenomatous polyps via colonoscopy represent the most effective strategy for colorectal cancer prevention. Intestinal adenomas often present without specific clinical symptoms in the early stage. By the time patients seek medical care due to symptomatic manifestations, most have progressed to the middle or advanced stage, which exerts severe adverse impacts on subsequent therapeutic outcomes and long-term survival prognosis.

Although colonoscopy serves as the primary modality for the early diagnosis of intestinal adenoma, it is an invasive procedure associated with poor adherence among some patients. In addition, primary medical institutions are constrained by limited medical resources. Accurate and timely early diagnosis of intestinal adenoma is closely linked to targeted clinical intervention and improved patient survival outcomes. Therefore, it is critical to identify an early diagnostic approach for intestinal adenoma that boasts high patient acceptance, low technical barriers, convenience and cost-effectiveness. In recent years, with the advancement and wider accessibility of data analytics tools such as artificial intelligence (AI), growing research efforts have focused on addressing this clinical challenge using AI algorithms. Laboratory testing is routinely performed in clinical practice and delivers timely results, and the massive volume of laboratory data provides evidence supporting early disease diagnosis and prognostic prediction. Advances in artificial intelligence enable clinicians to convert abundant clinical data into practical predictive models to enhance diagnostic performance. Accordingly, integrated analysis of electronic medical records and laboratory results using artificial intelligence facilitates timely detection and early diagnosis of intestinal adenoma, and ultimately improves patient survival prognosis.

02

Conditions studied

  • Colorectal Adenoma
  • Polyp

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Keywords

  • laboratory tests
  • Colorectal adenoma
  • polyp
  • precancerous lesion
03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 400 is above the median of 209 across 101 observational studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 86 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged ≥ 18 years undergoing colonoscopy, with 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 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.

Exclusion criteria

Exclusion Criteria:

  • Unavailable clinical data including laboratory test results;
  • Neoplastic lesions other than colorectal adenoma;
  • Non-first diagnosis of colorectal adenoma;
  • diseases;
  • Repeated enrolled subjects (duplicate patients);
  • Pregnancy or breastfeeding status;
  • Failure to obtain ;
  • The investigator considers that the subject has high-risk diseases or other special conditions unsuitable for participating in this clinical trial.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • All enrolled participants

    All subjects meeting inclusion criteria will be included in this single cohort. Participants will be divided into a retrospective training subset to construct the predictive model and a prospective validation subset to externally verify model performance for colorectal adenoma prediction.

    Other: No active intervention

Interventions

  • OtherNo active intervention

    This 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.

06

What researchers measure

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 enrollment

07

Study locations

1 site
08

References and documents

Publications

  • Rui F, Yeo YH, Tian X, Chen Y, Li J. Authors' reply to: Concerns Regarding "Development of a machine learning-based model to predict hepatic inflammation in chronic hepatitis B patients with concurrent hepatic steatosis: a cohort study". EClinicalMedicine. 2024 Nov 14;78:102908. doi: 10.1016/j.eclinm.2024.102908. eCollection 2024 Dec. No abstract available. PubMed 39619238 ↗
  • Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6. PubMed 30738046 ↗
  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. PubMed 35020204 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared publicly to protect patient privacy and comply with institutional data management regulations. No predefined data sharing plan has been established for this study.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 28, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Sep 1, 2028
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793110
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Yu Honggang (Chief Physician, Renmin Hospital of Wuhan University) — Principal investigator
First posted
Aug 28, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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