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NCT Number: NCT07611266

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Shutian Zhang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Advanced Adenoma Recurrence

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

Secondary outcomes

  1. Adenoma Recurrence

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

Other outcomes

  1. Carcinogenesis

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hongtao Wei

CONTACT

[email protected]

+86 13811216906

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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