Prediction Model of Colorectal Adenoma Recurrence-Carcinogenesis Risk With TCM-WM Multimodal Feature Fusion

NCT07611266 | Recruiting DMC

• 1 other identifier: 2024ZD0520802
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Control and Prevention

Outcome Measures

Primary Outcomes (1)

• Advanced Adenoma Recurrence

  From enrollment to study completion, up to 3 years (average 1.5 years)

Secondary Outcomes (1)

• Adenoma Recurrence

  From enrollment to study completion, up to 3 years (average 1.5 years)

Other Outcomes (1)

• Carcinogenesis

  From enrollment to study completion, up to 3 years (average 1.5 years)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 38901991 RESULT

• 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.

  PMID: 31127882 RESULT

• 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.

  PMID: 34069132 RESULT

• Kanth P, Inadomi JM. Screening and prevention of colorectal cancer. BMJ. 2021 Sep 15;374:n1855. doi: 10.1136/bmj.n1855.

  PMID: 34526356 RESULT

• 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.

  PMID: 37621242 RESULT

• 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.

  PMID: 33518157 RESULT

Central Study Contacts

Hongtao Wei

CONTACT

+86 13811216906; gulvzhe@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Gastroenterology Department

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)