Evaluation of Artificial Intelligence System in Diagnosis of Colorectal Tubular Adenoma Lesions

NCT ID: NCT07073430

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-10-31

Brief Summary

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This study is a prospective,multi-center and observational clinical study.Investigators would like to innovatively construct a "trinity" database of colorectal tubular adenomas based on white light - magnifying chromo - pathological images.It simulates the decision - making logic of doctors, and based on the multimodal endoscopic LAFEQ method previously proposed, develop a multimodal deep - learning diagnostic model for colon adenomas and an interpretable risk prediction model for intestinal adenomas. While achieving high - precision auxiliary treatment decisions, clearly present the decision - making basis, and break through the limitation of poor interpretability of previous medical imaging AI models.

Detailed Description

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Conditions

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Colorectal Adenoma Artificial Intelligence (AI) in Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traditional colonoscopy examination group

the system shows the original colonoscopy video.

No interventions assigned to this group

AI-assisted colonoscopy examination group

the system presents the detected polyp location with a hollow blue alert box directly on a high definition monitor,marking whether it is an adenoma or not and the probability of it.

AI models with NBI

Intervention Type DEVICE

AI models for detecting intestinal adenoma in magnifying endoscopy with NBI.

Interventions

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AI models with NBI

AI models for detecting intestinal adenoma in magnifying endoscopy with NBI.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged ≥ 18 years, who need to undergo colonoscopy, regardless of gender.
* Voluntarily sign the informed consent form
* Promise to abide by the research procedures and cooperate in the implementation of the entire research process.

Exclusion Criteria

* Patients who has a history of abdominal or pelvic surgery or radiotherapy in the past;
* Patients who has definite active lower gastrointestinal bleeding.
* Existing or suspected hereditary colorectal polyposis, inflammatory bowel disease;
* Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg after standardized treatment)
* There is a history of stroke, coronary artery disease, or vascular disease;
* Pregnant;
* Intestinal preparation cannot be carried out.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital, Captial Medical University

UNKNOWN

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

The Sixth Affiliated Hospital, Sun Yat-sen University

UNKNOWN

Sponsor Role collaborator

Army Medical University, China

OTHER

Sponsor Role collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role collaborator

The Second Medical Center of The General Hospital of the People's Liberation Army

UNKNOWN

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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ChenMingkai

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingkai Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingkai Chen, PHD

Role: CONTACT

+86 13720330580

Facility Contacts

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Mingkai Chen, doctor

Role: primary

13720330580

References

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Strum WB. Colorectal Adenomas. N Engl J Med. 2016 Mar 17;374(11):1065-75. doi: 10.1056/NEJMra1513581. No abstract available.

Reference Type BACKGROUND
PMID: 26981936 (View on PubMed)

Glissen Brown JR, Mansour NM, Wang P, Chuchuca MA, Minchenberg SB, Chandnani M, Liu L, Gross SA, Sengupta N, Berzin TM. Deep Learning Computer-aided Polyp Detection Reduces Adenoma Miss Rate: A United States Multi-center Randomized Tandem Colonoscopy Study (CADeT-CS Trial). Clin Gastroenterol Hepatol. 2022 Jul;20(7):1499-1507.e4. doi: 10.1016/j.cgh.2021.09.009. Epub 2021 Sep 14.

Reference Type BACKGROUND
PMID: 34530161 (View on PubMed)

Yao L, Li X, Wu Z, Wang J, Luo C, Chen B, Luo R, Zhang L, Zhang C, Tan X, Lu Z, Zhu C, Huang Y, Tan T, Liu Z, Li Y, Li S, Yu H. Effect of artificial intelligence on novice-performed colonoscopy: a multicenter randomized controlled tandem study. Gastrointest Endosc. 2024 Jan;99(1):91-99.e9. doi: 10.1016/j.gie.2023.07.044. Epub 2023 Aug 1.

Reference Type BACKGROUND
PMID: 37536635 (View on PubMed)

Wallace MB, Sharma P, Bhandari P, East J, Antonelli G, Lorenzetti R, Vieth M, Speranza I, Spadaccini M, Desai M, Lukens FJ, Babameto G, Batista D, Singh D, Palmer W, Ramirez F, Palmer R, Lunsford T, Ruff K, Bird-Liebermann E, Ciofoaia V, Arndtz S, Cangemi D, Puddick K, Derfus G, Johal AS, Barawi M, Longo L, Moro L, Repici A, Hassan C. Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007. Epub 2022 Mar 15.

Reference Type BACKGROUND
PMID: 35304117 (View on PubMed)

Haight TJ, Eshaghi A. Deep Learning Algorithms for Brain Imaging: From Black Box to Clinical Toolbox? Neurology. 2023 Mar 21;100(12):549-550. doi: 10.1212/WNL.0000000000206808. Epub 2023 Jan 13. No abstract available.

Reference Type BACKGROUND
PMID: 36639238 (View on PubMed)

Stahlschmidt SR, Ulfenborg B, Synnergren J. Multimodal deep learning for biomedical data fusion: a review. Brief Bioinform. 2022 Mar 10;23(2):bbab569. doi: 10.1093/bib/bbab569.

Reference Type BACKGROUND
PMID: 35089332 (View on PubMed)

van der Velden BHM, Kuijf HJ, Gilhuijs KGA, Viergever MA. Explainable artificial intelligence (XAI) in deep learning-based medical image analysis. Med Image Anal. 2022 Jul;79:102470. doi: 10.1016/j.media.2022.102470. Epub 2022 May 4.

Reference Type BACKGROUND
PMID: 35576821 (View on PubMed)

Wang Y, Zhen L, Tan TE, Fu H, Feng Y, Wang Z, Xu X, Goh RSM, Ng Y, Calhoun C, Tan GSW, Sun JK, Liu Y, Ting DSW. Geometric Correspondence-Based Multimodal Learning for Ophthalmic Image Analysis. IEEE Trans Med Imaging. 2024 May;43(5):1945-1957. doi: 10.1109/TMI.2024.3352602. Epub 2024 May 2.

Reference Type BACKGROUND
PMID: 38206778 (View on PubMed)

Tempany CM, Jayender J, Kapur T, Bueno R, Golby A, Agar N, Jolesz FA. Multimodal imaging for improved diagnosis and treatment of cancers. Cancer. 2015 Mar 15;121(6):817-27. doi: 10.1002/cncr.29012. Epub 2014 Sep 9.

Reference Type BACKGROUND
PMID: 25204551 (View on PubMed)

Zhou T, Cheng Q, Lu H, Li Q, Zhang X, Qiu S. Deep learning methods for medical image fusion: A review. Comput Biol Med. 2023 Jun;160:106959. doi: 10.1016/j.compbiomed.2023.106959. Epub 2023 Apr 20.

Reference Type BACKGROUND
PMID: 37141652 (View on PubMed)

Dekker E, Rex DK. Advances in CRC Prevention: Screening and Surveillance. Gastroenterology. 2018 May;154(7):1970-1984. doi: 10.1053/j.gastro.2018.01.069. Epub 2018 Feb 15.

Reference Type BACKGROUND
PMID: 29454795 (View on PubMed)

Li J, Zhu Y, Dong Z, He X, Xu M, Liu J, Zhang M, Tao X, Du H, Chen D, Huang L, Shang R, Zhang L, Luo R, Zhou W, Deng Y, Huang X, Li Y, Chen B, Gong R, Zhang C, Li X, Wu L, Yu H. Development and validation of a feature extraction-based logical anthropomorphic diagnostic system for early gastric cancer: A case-control study. EClinicalMedicine. 2022 Mar 30;46:101366. doi: 10.1016/j.eclinm.2022.101366. eCollection 2022 Apr.

Reference Type BACKGROUND
PMID: 35521066 (View on PubMed)

Other Identifiers

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WDRY2024-K153

Identifier Type: -

Identifier Source: org_study_id

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