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.
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.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130021
Mingqing Liu, +8613204300453, liumq23@jlu.edu.cn
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.
- Conditions
- Colorectal Polyp
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value
Measured: 2025-12-31
sensitivity
Measured: 2025-12-31
specificity
Measured: 2025-12-31
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.
- First posted24 Jan 2025
- Study start5 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Xu, Docror, Principal investigator, The First Hospital of Jilin University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Accuracy of Real-time AI-assisted Endocytoscopy in the Diagnosis of Colorectal Diminutive Polyps
- ClinicalTrials.gov ID
- NCT06791408
- Acronym / sponsor ID
- 25K014-001
- Conditions
- Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with colorectal lesions
Key inclusion criteria (1 listed)
- colorectal lesions
Key exclusion criteria (4 listed)
- 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.
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
Negative predictive value
Time frame: 2025-12-31
sensitivity
Time frame: 2025-12-31
specificity
Time frame: 2025-12-31
accurary
Time frame: 2025-12-31
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 7 Mar 2025.
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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.
Hong Xu, Docror principal investigator
The First Hospital of Jilin University
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 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.