- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07611266
Prediction Model of Colorectal Adenoma Recurrence-Carcinogenesis Risk With TCM-WM Multimodal Feature Fusion
20. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
3000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hongtao Wei
- Telefonnummer: +86 13811216906
- E-mail: gulvzhe@126.com
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100000
- Rekruttering
- Beijing Friendship Hospital Affiliated to Capital Medical University
-
Kontakt:
- Shutian Zhang
- E-mail: zhangstyy@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Advanced Adenoma Recurrence
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adenoma Recurrence
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Carcinogenesis
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2025
Primær færdiggørelse (Anslået)
30. maj 2028
Studieafslutning (Anslået)
30. november 2028
Datoer for studieregistrering
Først indsendt
27. april 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024ZD0520802
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kolorektal cancer kontrol og forebyggelse
-
Bambino Gesù Hospital and Research InstituteAfsluttetSvær pædiatrisk fedme (BMI > 97° pc -Ifølge Centers for Disease Control and Prevention BMI-diagrammer-) | Ændrede leverfunktionstests | Glykæmisk intoleranceItalien