EndocytoscopyNCT06982872
Comparison of the Diagnostic Performance of Different Artificial Intelligence Assisted Endocytoscopy for Colorectal Lesions
An observational study of Endocytoscopy, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Colorectal cancer (colorectal cancer, CRC) is the third most common malignant tumor globally and the second leading cause of cancer-related deaths. Colonoscopy is considered the preferred method for screening colorectal cancer; early detection and removal of colorectal neoplasms can significantly reduce the incidence… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endocytoscopy
- What is being tested?
- artificial intelligence
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 21 May 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
- 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 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 (colorectal cancer, CRC) is the third most common malignant tumor globally and the second leading cause of cancer-related deaths. Colonoscopy is considered the preferred method for screening colorectal cancer; early detection and removal of colorectal neoplasms can significantly reduce the incidence and mortality of colorectal cancer. To improve the diagnostic accuracy of endoscopy in colorectal lesions, many endoscopic techniques have been applied clinically, such as image-enhanced endoscopy, including narrow band imaging (narrow-band imaging, NBI), magnifying endoscopy, chromoendoscopy, confocal laser endoscopy, and endocytoscopy (EC). However, with the increasing number of endoscopic resections, the costs associated with the pathological diagnosis of resected specimens have risen year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to differentiate the nature of lesions during colonoscopy.
Endocytoscopy is an ultra-high magnification endoscope that, when combined with chemical staining and narrowband imaging techniques, allows endoscopists to observe the nuclear morphology of colorectal lesions, the shape of glands, and the morphology of microvessels with the naked eye, thus avoiding pathological examination and achieving the goal of real-time biopsy in vivo. However, the accuracy of endocytoscopy images requires extensive experience accumulation to improve judgment, and there is a certain degree of subjectivity and error in the process of endoscopists making judgments. Therefore, to address this issue, clinical applications have proposed using artificial intelligence (AI) for computer-aided diagnosis. Currently, Japan has developed an endoscopic cytology auxiliary diagnostic system-EndoBRAIN, based on the Japanese population, which uses support vector machines to build model. The investigator's center has developed a deep learning-based endoscopic cytology AI auxiliary diagnostic system for Chinese populations to assist in determining the nature of colorectal lesions. There is currently a lack of comparative studies on the diagnostic performance of these two systems, so the investigator aim to conduct a clinical study to compare and analyze the differences between the two AI auxiliary diagnostic systems.
- Conditions
- Endocytoscopy
- Being tested
- artificial intelligence
- Keywords
- endocytoscopy, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligenceDiagnostic test
Different AI assisted diagnostic systems are used to diagnose lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
of the intracellular AI platform for diagnosing colorectal neoplastic lesions was not inferior to that of EndoBRAIN.
Measured: 2025-12-31
Secondary outcomes (8)
the accuracy of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Measured: 2025-12-31
specificity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Measured: 2025-12-31
positive predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Measured: 2025-12-31
negative predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Measured: 2025-12-31
the accuracy of two AI assisted diagnostic systems for diagnosing colorectal invasive cancer
Measured: 2025-12-31
The accuracy of two AI assisted diagnostic systems in diagnosing lesions of the rectoileal colon ≤5 mm
Measured: 2025-12-31
the high confidence diagnosis rate of two AI assisted diagnostic systems for diagnosing colorectal lesions
Measured: 2025-12-31
the diagnostic time of two artificial intelligence assisted diagnosis systems
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 posted21 May 2025
- Study start21 May 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 EndocytoscopyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Xu, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982872
- Sponsor's protocol ID
- 25K189-001
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Performance of Different Artificial Intelligence Assisted Endocytoscopy for Colorectal Lesions
- ClinicalTrials.gov ID
- NCT06982872
- Acronym / sponsor ID
- 25K189-001
- Conditions
- Endocytoscopy
- Keywords
- endocytoscopy, artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 May 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 (colorectal cancer, CRC) is the third most common malignant tumor globally and the second leading cause of cancer-related deaths. Colonoscopy is considered the preferred method for screening colorectal cancer; early detection and removal of colorectal neoplasms can significantly reduce the incidence and mortality of colorectal cancer. To improve the diagnostic accuracy of endoscopy in colorectal lesions, many endoscopic techniques have been applied clinically, such as image-enhanced endoscopy, including narrow band imaging (narrow-band imaging, NBI), magnifying endoscopy, chromoendoscopy, confocal laser endoscopy, and endocytoscopy (EC). However, with the increasing number of endoscopic resections, the costs associated with the pathological diagnosis of resected specimens have risen year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to differentiate the nature of lesions during colonoscopy.
Endocytoscopy is an ultra-high magnification endoscope that, when combined with chemical staining and narrowband imaging techniques, allows endoscopists to observe the nuclear morphology of colorectal lesions, the shape of glands, and the morphology of microvessels with the naked eye, thus avoiding pathological examination and achieving the goal of real-time biopsy in vivo. However, the accuracy of endocytoscopy images requires extensive experience accumulation to improve judgment, and there is a certain degree of subjectivity and error in the process of endoscopists making judgments. Therefore, to address this issue, clinical applications have proposed using artificial intelligence (AI) for computer-aided diagnosis. Currently, Japan has developed an endoscopic cytology auxiliary diagnostic system-EndoBRAIN, based on the Japanese population, which uses support vector machines to build model. The investigator's center has developed a deep learning-based endoscopic cytology AI auxiliary diagnostic system for Chinese populations to assist in determining the nature of colorectal lesions. There is currently a lack of comparative studies on the diagnostic performance of these two systems, so the investigator aim to conduct a clinical study to compare and analyze the differences between the two AI auxiliary diagnostic systems.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- 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 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artificial intelligenceDifferent AI assisted diagnostic systems are used to diagnose lesions. | Diagnostic test | – |
Primary outcome
the sensitivity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Time frame: 2025-12-31
of the intracellular AI platform for diagnosing colorectal neoplastic lesions was not inferior to that of EndoBRAIN.
8 secondary outcomes
the accuracy of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Time frame: 2025-12-31
specificity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Time frame: 2025-12-31
positive predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Time frame: 2025-12-31
negative predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms
Time frame: 2025-12-31
the accuracy of two AI assisted diagnostic systems for diagnosing colorectal invasive cancer
Time frame: 2025-12-31
The accuracy of two AI assisted diagnostic systems in diagnosing lesions of the rectoileal colon ≤5 mm
Time frame: 2025-12-31
the high confidence diagnosis rate of two AI assisted diagnostic systems for diagnosing colorectal lesions
Time frame: 2025-12-31
the diagnostic time of two artificial intelligence assisted diagnosis systems
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 25 May 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.
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 Endocytoscopy, 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 25 May 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, Doctor (15043076005, 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?
the sensitivity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms (time frame: 2025-12-31). 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 25 May 2025.