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Colorectal PolypNCT06791408

Clinical Study on the Accuracy of Real-time AI-assisted Endocytoscopy in the Diagnosis of Colorectal Diminutive Polyps

An observational study of Colorectal Polyp, run by The First Hospital of Jilin University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Colorectal cancer (CRC) is the third most common malignant tumor in the world and the second largest cause of cancer-related death [1]. Colonoscopy is considered the preferred method of screening for colorectal cancer, and early and resectable detection of colorectal neoplastic lesions can significantly reduce… Read more about this study

Who is it for?
Any age
Conditions the study is for
Colorectal Polyp
How many people
600 participants
Where
1 siteChina
Study dates
5 Feb 2025to 31 Dec 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: patients with colorectal lesions

Who may be able to join

  • colorectal lesions

Who cannot join

  • lesions lacking high-quality images;
  • Inflammatory bowel disease, familial adenomatous polyposis and other special diseases;
  • submucosal tumors;
  • Pathological diagnosis of inflammatory polyps, Peutz-Jeghers polyps, juvenile polyps, lymphoma and other pathological types.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mingqing Liu, Docror contact

+8613204300453

liumq23@mails.jlu.edu.cn

China1 site, 1 recruiting
  • First Hospital of Jilin University

    Changchun, Jilin, 130021

    Mingqing Liu, +8613204300453, liumq23@jlu.edu.cn

    Recruiting

Other trials in China

About this study

Colorectal cancer (CRC) is the third most common malignant tumor in the world and the second largest cause of cancer-related death [1]. Colonoscopy is considered the preferred method of screening for colorectal cancer, and early and resectable detection of colorectal neoplastic lesions can significantly reduce colorectal cancer morbidity and mortality. In recent years, with the continuous development of endoscopic diagnostic techniques and the standardization and strengthening of endoscopist training, the detection rate of colorectal polyps has increased year by year. As the number of endoscopic excisions increases, the costs associated with endoscopic excision and pathological diagnosis of excised specimens increase year by year. Research results showed that about 90% of the detected polyps were small polyps (6-9 mm) and diminutive polyps (≤5 mm), and nearly half of them were non-neoplastic polyps, so endoscopic resection and histopathological examination were not required [2, 3]. In order to reduce unnecessary pathological examination and endoscopic treatment, the American Society of Digestive Endoscopy proposed PIVI strategies: "excise and discard" and "diagnose and do not excise" strategies.

Endocytoscopy is a kind of ultra-high magnification endoscopy. Combined with chemical staining and narrow-band imaging technology, endoscopists can observe and judge the nuclear morphology, glandular duct morphology and microvascular morphology of colorectal lesions by naked eye, thus realizing the purpose of real-time biopsy in vivo. However, it takes a lot of experience accumulation to improve the judgment accuracy of endoscopy images, and endoscopy doctors have certain subjective judgments and errors in the process of judging results. Therefore, in order to solve this problem, Artificial Intelligence (AI) is proposed clinically. Our center has developed an artificial intelligence assisted diagnosis system based on endocytoscopy to assist endocytoscopy in judging the nature of colorectal lesions. However, whether this artificial intelligence assisted diagnosis system is accurate in judging the nature of colorectal diminutive polyps and is suitable for widespread promotion and application of PIVI strategy lacks relevant clinical data. This study intends to carry out this clinical study to verify the diagnostic accuracy of this artificial intelligence in the diagnosis of colorectal diminutive polyps.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Negative predictive value

    Measured: 2025-12-31

  2. sensitivity

    Measured: 2025-12-31

  3. specificity

    Measured: 2025-12-31

  4. accurary

    Measured: 2025-12-31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start5 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06791408
Sponsor's protocol ID
25K014-001
Status last verified
Jan 2025
First submitted
20 Jan 2025
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Polyp, run by The First Hospital of Jilin University 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 1 inclusion and 4 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 7 Mar 2025. 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 Mingqing Liu, Docror (+8613204300453, liumq23@mails.jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Negative predictive value (time frame: 2025-12-31). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Mar 2025.

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