- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611266
Prediction Model of Colorectal Adenoma Recurrence-Carcinogenesis Risk With TCM-WM Multimodal Feature Fusion
May 20, 2026 updated by: Hongtao Wei, Beijing Friendship Hospital
Study on the Prediction Model of Recurrence and Carcinogenesis Risk of Colorectal Adenoma Based on the Fusion of Traditional Chinese and Western Medicine Multimodal Features
This project focuses on developing a risk prediction model for the recurrence and malignant transformation of colorectal adenomas by integrating multimodal features from both Traditional Chinese Medicine (TCM) and Western medicine.
Led by Dr. Wei Hongtao from Beijing Friendship Hospital, Capital Medical University, the primary objective is to mine clinical characteristics from both medical systems to construct a robust predictive model.
The research encompasses several key aspects: a multicenter, large-sample cohort study design with a clearly defined sample size and calculation basis; patient recruitment from multiple institutions nationwide to form training and validation sets; and strict adherence to standardized TCM and Western diagnostic criteria.
Through comprehensive observation of demographic, TCM clinical (e.g., syndromes, tongue and pulse diagnosis), and Western clinical features, the study ensures data accuracy via rigorous monitoring and follow-up.
Various algorithms are employed to extract and analyze these multi-source features-including endoscopic data-to build and evaluate the prediction model.
Furthermore, the study aims to identify dominant subgroups to optimize TCM intervention strategies.
Key performance indicators include establishing the risk model, identifying target populations, publishing high-quality papers, and training graduate students.
By innovatively constructing this multimodal fusion model, the project provides a novel perspective and evidence-based foundation for the prevention and treatment of colorectal adenomas using TCM.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongtao Wei
- Phone Number: +86 13811216906
- Email: gulvzhe@126.com
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100000
- Recruiting
- Beijing Friendship Hospital Affiliated to Capital Medical University
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Contact:
- Shutian Zhang
- Email: zhangstyy@163.com
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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
No
Sampling Method
Probability Sample
Study Population
Prospective inclusion of patients with pathologically diagnosed colorectal adenomas from 2025 in Beijing Friendship Hospital Affiliated to Capital Medical University, Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Cancer Hospital of the Chinese Academy of Medical Sciences, and Beihang University
Description
Inclusion Criteria:
- Meet the diagnostic criteria for colorectal adenoma (Western medicine) and the relevant TCM syndromes.
- Aged 18 years or older.
- Willing to undergo regular follow-up examinations (including colonoscopy and laboratory tests) and sign the informed consent form.
Exclusion Criteria:
- Pregnant or lactating women.
- History of Crohn's disease, ulcerative colitis, or other malignancies.
- Previous history of radiotherapy, chemotherapy, or gastrointestinal surgery.
- Hereditary polyposis syndromes (e.g., familial adenomatous polyposis, MUTYH-associated polyposis, or hamartomatous polyposis syndrome).
- Severe cognitive impairment, dementia, or mental illness.
- Severe cardiovascular or cerebrovascular diseases, or hematological system disorders.
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
Cohorts and Interventions
Group / Cohort |
|---|
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Colorectal Adenoma
Patients diagnosed with colorectal adenoma who have undergone endoscopic resection (including endoscopic mucosal resection [EMR], endoscopic submucosal dissection [ESD], or cold snare polypectomy [CSP], as appropriate for lesion characteristics) and whose resected specimen has been pathologically confirmed as colorectal adenoma (excluding adenocarcinoma, hyperplastic polyps, or other non-adenomatous lesions) are eligible for enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Advanced Adenoma Recurrence
Time Frame: From enrollment to study completion, up to 3 years (average 1.5 years)
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From enrollment to study completion, up to 3 years (average 1.5 years)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adenoma Recurrence
Time Frame: From enrollment to study completion, up to 3 years (average 1.5 years)
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From enrollment to study completion, up to 3 years (average 1.5 years)
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Carcinogenesis
Time Frame: From enrollment to study completion, up to 3 years (average 1.5 years)
|
From enrollment to study completion, up to 3 years (average 1.5 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang RJ, Zhang XL, Cai JD, Wang MH, Liu JQ, Xu Y. [Standardized diagnosis and treatment of colorectal polyps]. Zhonghua Wei Chang Wai Ke Za Zhi. 2024 Jun 25;27(6):583-590. doi: 10.3760/cma.j.cn441530-20240416-00143. Chinese.
- Roslan NH, Makpol S, Mohd Yusof YA. A Review on Dietary Intervention in Obesity Associated Colon Cancer. Asian Pac J Cancer Prev. 2019 May 25;20(5):1309-1319. doi: 10.31557/APJCP.2019.20.5.1309.
- Terasaki M, Kubota A, Kojima H, Maeda H, Miyashita K, Kawagoe C, Mutoh M, Tanaka T. Fucoxanthin and Colorectal Cancer Prevention. Cancers (Basel). 2021 May 14;13(10):2379. doi: 10.3390/cancers13102379.
- Kanth P, Inadomi JM. Screening and prevention of colorectal cancer. BMJ. 2021 Sep 15;374:n1855. doi: 10.1136/bmj.n1855.
- Kim SH, Park DH, Lim YJ. Impact of Diet on Colorectal Cancer Progression and Prevention: From Nutrients to Neoplasms. Korean J Gastroenterol. 2023 Aug 25;82(2):73-83. doi: 10.4166/kjg.2023.079.
- Zhou E, Rifkin S. Colorectal Cancer and Diet: Risk Versus Prevention, Is Diet an Intervention? Gastroenterol Clin North Am. 2021 Mar;50(1):101-111. doi: 10.1016/j.gtc.2020.10.012.
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 (Actual)
June 1, 2025
Primary Completion (Estimated)
May 30, 2028
Study Completion (Estimated)
November 30, 2028
Study Registration Dates
First Submitted
April 27, 2026
First Submitted That Met QC Criteria
May 20, 2026
First Posted (Actual)
May 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2024ZD0520802
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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