Colorectal Cancer Control and PreventionNCT07611266
Prediction Model of Colorectal Adenoma Recurrence-Carcinogenesis Risk With TCM-WM Multimodal Feature Fusion
An observational study of Colorectal Cancer Control and Prevention, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Control and Prevention
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Nov 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000
Shutian Zhang, zhangstyy@163.com
About this study
Official 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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Advanced Adenoma Recurrence
Measured: From enrollment to study completion, up to 3 years (average 1.5 years)
Secondary outcomes (1)
Adenoma Recurrence
Measured: From enrollment to study completion, up to 3 years (average 1.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2025
- Primary completion30 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongtao Wei, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611266
- Sponsor's protocol ID
- 2024ZD0520802
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38901991Roslan 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.
PubMed 31127882Terasaki 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.
PubMed 34069132Kanth P, Inadomi JM. Screening and prevention of colorectal cancer. BMJ. 2021 Sep 15;374:n1855. doi: 10.1136/bmj.n1855.
PubMed 34526356Kim 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.
PubMed 37621242Zhou 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.
PubMed 33518157
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07611266
- Acronym / sponsor ID
- 2024ZD0520802
- Conditions
- Colorectal Cancer Control and Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Advanced Adenoma Recurrence
Time frame: From enrollment to study completion, up to 3 years (average 1.5 years)
1 secondary outcome
Adenoma Recurrence
Time frame: From enrollment to study completion, up to 3 years (average 1.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Results publication: PubMed 38901991Wang 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.
- Results publication: PubMed 31127882Roslan 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.
- Results publication: PubMed 34069132Terasaki 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.
- Results publication: PubMed 34526356Kanth P, Inadomi JM. Screening and prevention of colorectal cancer. BMJ. 2021 Sep 15;374:n1855. doi: 10.1136/bmj.n1855.
- Results publication: PubMed 37621242Kim 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.
- Results publication: PubMed 33518157Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Control and Prevention, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongtao Wei (+86 13811216906, gulvzhe@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced Adenoma Recurrence (time frame: From enrollment to study completion, up to 3 years (average 1.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07611266, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.