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

Capital Medical University

Status: Enrolling

Conditions: Colorectal Cancer Control and Prevention

Study type: Observational

Funder types: Other

Identifiers

NCT07611266

2024ZD0520802

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

Colorectal Adenoma

Description:

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.